MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-31 for BENDING IRON FOR 2.7MM & 3.5MM PLATES 329.050 manufactured by Synthes Bettlach.
[23327391]
Device was used for treatment, not diagnosis. Additional narrative: unknown. Device is an instrument and is not implanted/explanted. A device history record review was attempted for the subject device lot. The review showed that the subject device is over 15 years old. Device history documents are only retained for 10 years. The 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
[23327392]
Device report from synthes (b)(4) reported an event in (b)(6) as follows: it was reported that the bending iron was received from the facility with a piece broken off from one end. The broken piece was not returned with the device. There was no report of patient or surgical involvement. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[30276437]
Additional narrative: a product investigation was completed: our investigation of the returned bending iron has shown that a part of the end by the groove is broken off. The broken part was not returned for the investigation. The device history record was researched, no abnormal findings were identified. There were no issues during the manufacturing of the product that would contribute to this complaint condition. Further investigation has shown that this instrument was manufactured in december 1997. Based on these findings and as this instrument is now more than 17 years old we determine the complained malfunction as wear and tear after frequent use over the years. 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 | 9612488-2015-10393 |
| MDR Report Key | 4957552 |
| Date Received | 2015-07-31 |
| Date of Report | 2015-07-20 |
| Date Mfgr Received | 2015-09-09 |
| Device Manufacturer Date | 1997-12-30 |
| Date Added to Maude | 2015-07-31 |
| 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 BETTLACH |
| Manufacturer Street | MURACHERSTRASSE 3 |
| Manufacturer City | BETTLACH CH2544 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH2544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BENDING IRON FOR 2.7MM & 3.5MM PLATES |
| Generic Name | INSTRUMENT, BENDING OR CONTOURING |
| Product Code | HXP |
| Date Received | 2015-07-31 |
| Returned To Mfg | 2015-07-29 |
| Catalog Number | 329.050 |
| Lot Number | 6003 |
| 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 BETTLACH |
| Manufacturer Address | MURACHERSTRASSE 3 BETTLACH CH2544 SZ CH2544 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-31 |