MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-08-14 for COMPRESSION/DISTRACTION HOLDING SLEEVE/2.5MM K-WIRE 03.111.023 manufactured by Wrights Lane Synthes Usa Products Llc.
[154450981]
The compression/distraction holding sleeve/2. 5 mm k-wire (p/n 03. 111. 023 lot unk) was received showing the three most proximal thread forms stripped. The shaft is also significantly scratched at the area of interface with a compression/distraction device (intended mating instrument). Due to the scratches, the lot number etch is illegible. During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition. The complaint condition is confirmed for the compression/distraction holding sleeve/2. 5 mm k-wire (p/n 03. 111. 023 lot unk) as the three most proximal thread forms were stripped. The shaft is also significantly scratched at the area of interface with a compression/distraction device (intended mating instrument). Due to the scratches, the lot number etch is illegible. While no definitive root cause could be determined, it is likely that the condition of the device was due to normal wear from consistent use and reprocessing over its lifetime (2+ years). During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. 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
[154450982]
It was reported on (b)(6) 2019, during an inventory of the foot instrument set, it was noticed that one of the compression or distraction holding sleeves, the thread are stripping and is not working correctly. There was no patient involvement. This report is for one (1) compression/distraction holding sleeve/2. 5 mm k-wire. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2019-59817 |
| MDR Report Key | 8893087 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-08-14 |
| Date of Report | 2019-07-17 |
| Date Mfgr Received | 2019-07-17 |
| Date Added to Maude | 2019-08-14 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | WERK BETTLACH (CH) |
| Manufacturer Street | MURACHERSTRASSE 3 |
| Manufacturer City | BETTLACH 2544 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPRESSION/DISTRACTION HOLDING SLEEVE/2.5MM K-WIRE |
| Generic Name | INSTRUMENT COMPRESSION |
| Product Code | HWN |
| Date Received | 2019-08-14 |
| Returned To Mfg | 2019-07-29 |
| Model Number | 03.111.023 |
| Catalog Number | 03.111.023 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHTS LANE SYNTHES USA PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-14 |