MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,company representative report with the FDA on 2015-06-23 for ALIF SIZER HANDLE 389.150 manufactured by Synthes Monument.
[17542821]
It was reported that part # 389. 150, lot# 7858-1? The threaded tip of the inner shaft broke off. A distractor bullet was left on the tip during the cleaning process. The pan holding the items fell on the floor and the tip with the bullet broke off and was lost. It was also reported that part # 389. 150 lot l# u126012? The threads on the end are worn down and smooth, no reported case or patient impact. These events occurred in sterile processing, not during surgery. No reported patient involvement or procedure harm noted. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[17908783]
Device was used for treatment, not diagnosis. No patient involvement device is an instrument and is not implanted/explanted. The investigation could not be completed; no conclusion could be drawn, as no product was received. Drh review? Envision manufacturing inc. Manufactured the alif sizer handle, p/n 389. 150, lot # 4667995, 4743077, 4761280, supplier lot # 7858-1. There were three dhr lots to review. Lot # 4667995: dated october 15, 2003, was for 12 parts. The certificate of compliance (dated october 13, 2003) indicates the part was manufactured to p/n 389. 150 and met the required specifications. The lot was inspected and conformed to the synthes incoming final inspection. There were no mrrs, ncrs, or complaint-related issues with this lot. 12 parts were released to the warehouse on october 16, 2003. Lot # 4743077 dated march 09, 2004, line 2, for 4 parts. The certificate of compliance (dated february 05, 2004) indicates the parts were manufactured to p/n 389. 150, and met the required specifications. The lot was inspected to the synthes incoming final inspection. Mrr was written for the m4 x 0. 7 - 6g, thread go / no-go gage? The no-go member of the gage was nonconforming on 1 part out of 4 in the lot. One part was returned to the supplier (rts) and the mrr was closed on march 11, 2004. 3 parts were released to the warehouse on march 26, 2004. Lot # 4761280: dated april 08, 2004, was for 1 part. The certificate of compliance (dated april 07, 2004) indicates the part was manufactured to p/n 389. 150, and met the required specifications. The lot was inspected and conformed to the synthes incoming final inspection. There were no mrrs, ncrs, or complaint-related issues with this lot. One part was released to the warehouse on april 20, 2004. The alif sizer handle was released on august 21, 2001. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[25060563]
Product investigation summary: two alif sizer handles (part 389. 150 / lot 7858-1 and u126012) were returned with the following complaint descriptions:? The threaded tip of the inner shaft broke off? [and]? The threads on the end are worn down and smooth?. The returned instruments were examined and the complaint conditions were able to be confirmed. The root cause for lot 7858-1 was deemed misuse/abuse as the complaint description notes that the instrument was dropped, causing the tip failure. The returned instruments were examined and in each instance the complaint condition was able to be confirmed. The threaded tip for lot 7858-1 is broken as the distal 5mm has broken off and was not returned. The material at the fracture site appears homogenous. Relevant drawings for the returned instrument were reviewed. The design, materials and finishing processes were found to be appropriate for the intended use of these devices. The device history record relating to the lot number for both returned parts was examined and no complaint-related issues were found. During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition. Device used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[27625720]
Subject device has been received; no conclusions could be drawn as the device is entering the complaint system. Device used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1719045-2015-10402 |
| MDR Report Key | 4861823 |
| Report Source | 07,COMPANY REPRESENTATIVE |
| Date Received | 2015-06-23 |
| Date of Report | 2015-06-10 |
| Date Mfgr Received | 2015-09-03 |
| Device Manufacturer Date | 2003-10-16 |
| Date Added to Maude | 2015-07-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES MONUMENT |
| Manufacturer Street | 1051 SYNTHES AVE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALIF SIZER HANDLE |
| Generic Name | HANDLE, SCALPEL |
| Product Code | GDZ |
| Date Received | 2015-06-23 |
| Returned To Mfg | 2015-08-26 |
| Catalog Number | 389.150 |
| Lot Number | 7858-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES MONUMENT |
| Manufacturer Address | 1051 SYNTHES AVE MONUMENT CO 80132 US 80132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-23 |