MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-12-21 for 14.0MM CANNULATED AWL 03.010.041 manufactured by Synthes Hagendorf.
[62969117]
Additional narrative: device was used for treatment, not diagnosis. No patient involvement. It is unknown when breakage occurred. Device is an instrument and is not implanted/explanted. A review of the device history records has been completed. Manufacturing location: (b)(4), manufacturing date: august 28, 2006. No non-conformance records were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. Subject device has been received and is currently in the evaluation process. 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
[62969118]
It was reported that an awl was discovered broken in a storage warehouse outside of hospital. No patient involvement was reported. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[65709767]
Product development investigation was performed on the returned subject device (14. 0mm cannulated awl, part # 03. 010. 041, lot # 1544254). The complaint condition is confirmed as the awl was received with a small semi-circular portion, approximately 2. 5mm across and 1. 5mm deep, broken from the distal tip of the device. The broken portion was not received. A device history record (dhr) review, visual inspection, and drawing review were performed as part of this investigation. The returned part was determined to be suitable for the intended use when employed as recommended. The returned awl (03. 010. 041) is included in a variety of trauma nail sets, including the titanium cannulated retrograde/antegrade femoral nail (rafn), titanium cannulated adolescent lateral entry femoral nail, and the titanium cannulated lateral entry femoral recon nail systems. The technique guide for the titanium cannulated rafn states that the awl (03. 010. 041) is used over a guide wire and is an alternative instrument designed to manually open the medullary canal for 9. 0mm to 13. 0mm nails. The awl was received with a small semi-circular portion, approximately 2. 5mm across and 1. 5mm deep, broken from the distal tip of the device. The broken portion was not received. The four (4) distal sharp edges show wear and small nicks over the full length. On the proximal end an area of flattening was observed consistent with light impact. Thus, the complaint condition is confirmed and consistent with the reported condition. Replication of the complaint condition is not applicable as the device is already broken. Based on the date of manufactured (28. Aug. 2006) the drawings 14mm cannulated awl and awe tip (component), reflecting the current and manufactured revision, were reviewed. During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition. The returned part was determined to be suitable for the intended use when employed as recommended. No definitive root cause was able to be determined as circumstances surrounding the event and over the devices roughly 10+ year lifespan are unknown. The returned part was determined to be suitable for the intended use when employed as recommended. Device was 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 | 3003875359-2016-10655 |
| MDR Report Key | 6193328 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-12-21 |
| Date of Report | 2016-11-30 |
| Date Mfgr Received | 2017-01-16 |
| Device Manufacturer Date | 2006-08-28 |
| Date Added to Maude | 2016-12-21 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES HAGENDORF |
| Manufacturer Street | IM BIFANG 6 |
| Manufacturer City | HAGENDORF CH4614 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH4614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 14.0MM CANNULATED AWL |
| Generic Name | AWL |
| Product Code | HWJ |
| Date Received | 2016-12-21 |
| Returned To Mfg | 2016-12-19 |
| Catalog Number | 03.010.041 |
| Lot Number | 1544254 |
| 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 HAGENDORF |
| Manufacturer Address | IM BIFANG 6 HAGENDORF CH4614 SZ CH4614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-21 |