MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-23 for RIB EXPANSION PLIERS 388.471 manufactured by Wrights Lane Synthes Usa Products Llc.
[184495240]
Complainant part is not expected to be returned for manufacturer review/investigation. Occupation: initial reporter is a synthes employee. A product investigation was completed: the complaint device was not received for investigation. The following investigation is based on the image provided images. The images were reviewed along with the relevant drawing and it was noted that the pliers were not broken. The complaint condition cannot be confirmed. Since the device was not returned, a dimensional inspection and a functional test were not able to be performed. A manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided. A definitive assignable root cause could not be determined based on the provided information. During the investigation no product design issues or discrepancies were observed (based on the images) 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
[184495241]
Device report from synthes (b)(6) reports an event as follows: it was reported the distraction pliers broke while distracting; it was noted the middle piece fell off and the lock impactor clip on the side broke. Concomitant: lock impactor (part 03. 641. 009, lot unknown, quantity (b)(4)). This report is for a distraction pliers. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01462 |
| MDR Report Key | 9866261 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-23 |
| Date of Report | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-23 |
| 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 | SYNTHES TUTTLINGEN |
| Manufacturer Street | UNTER HASSLEN 5 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RIB EXPANSION PLIERS |
| Generic Name | PLIERS, SURGICAL |
| Product Code | HTC |
| Date Received | 2020-03-23 |
| Model Number | 388.471 |
| Catalog Number | 388.471 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-23 |