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

Model Number 311.01

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is synthes sales representative.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 on an unknown date, while restocking the tray, the handle with mini quick coupling was noticed to have cracked down the center and is in half.This looks to be from old age.There was no patient involvement.This report is for one (1) handle with mini quick coupling.This is report 1 of 1 for (b)(4).

Event Description

It was reported that on an unknown date, while restocking the tray, the handle with mini quick coupling was noticed to have cracked down the center and is in half.This looks to be from old age.It has been used by many different accounts.It would be impossible to pinpoint where the damage occurred.This is very typical damage due to wear and tear.There was no patient involvement.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The customer reported that the handle with mini quick coupling was noticed to have cracked down the center and is in half.The repair technician reported that the handle is broken.Handle cracked/broken is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.Upon inspection, the handle of the returned device is broken.The broken handle has separated into 2 pieces.Hence, the complaint is conformed.Dimensional analysis was not performed due to post manufacturing damage.Although a definitive root cause could not be determined, it is possible that rough handling during use and/or processing could have contributed to the complaint condition.During the investigation no unidentified product design/manufacturing issues or discrepancies 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.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities device history lot part #: 311.01, synthes lot number: 5043087, release to warehouse date: 18-jul-2005, no ncr¿s were generated during production.The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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.

• Brand Name: HANDLE WITH MINI QUICK COUPLING
• Type of Device: TAP,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8703583
• MDR Text Key: 148162720
• Report Number: 2939274-2019-58685
• Device Sequence Number: 1
• Product Code: HWX
• UDI-Device Identifier: 10886982187192
• UDI-Public: (01)10886982187192
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 311.01
• Device Catalogue Number: 311.01
• Device Lot Number: 5043087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Date Manufacturer Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1