MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HANDLE WITH QUICK COUPLING, SMALL; TAP, BONE

Catalog Number 311.43

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

There is no patient involvement.Date of event: it is unknown when device broke.Device is an instrument and is not implanted/explanted.Part 311.43; synthes lot: 4642055; supplier lot: n/a; release to warehouse date: (b)(6) 2003; expiration date: n/a; manufactured by synthes (b)(4); the raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.No nonconformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.The instrument was received with the reported condition of ¿broken (2+ pieces) pre or post operatively/step unknown : nrm¿ the following investigation flow was performed: broken.It was visually observed that phenolic end cap (not returned) from the instrument has been broken off from the device as it can be seen that the peg like portion (not returned) of the phenolic handle (proximal end) that holds the end cap has sheared off from the rest of the instrument.The complaint condition is confirmed and the received condition agrees with the complaint description.The cause of the issue could not be definitively traced to use error, misuse/abuse, non-compliance, postoperative trauma.A dimensional inspection could not be performed as the end cap was not returned.A device history review, was performed for the returned instrument¿s lot number and no material review reports (mrrs), ncrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.A review of the current design drawing and the drawing revision at the time of manufacture was performed: top level and subcomponents and no issues were identified.While no root cause could be determined it is likely that use of device for over 15+ years and with consistent sterile processing/rough handling could have contributed to the complaint condition.A material inspection was performed during the time of the device history record review and the raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.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.

Event Description

It was reported that during routine inspection of field equipment on an unknown date, it was discovered that the part that spins has broken off on a handle with quick coupling.The device was found with the broken handle when putting the instruments together.The age of the device is unknown, but it is believed to be quite old.There is no patient or procedure involvement.This report is for a handle with quick coupling, small.This is report 1 of 1 for (b)(4).

• Brand Name: HANDLE WITH QUICK COUPLING, SMALL
• Type of Device: TAP, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7808865
• MDR Text Key: 118002525
• Report Number: 2939274-2018-53440
• Device Sequence Number: 1
• Product Code: HWX
• UDI-Device Identifier: 10886982187390
• UDI-Public: (01)10886982187390
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 311.43
• Device Lot Number: 4642055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1