MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PROTECTION SLEEVE FOR 2.8MM VA DRILL GUIDE - LONG

Model Number	03.127.006
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.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 or Problem Description
It was reported that on (b)(6) 2019, a protection sleeve was bent when it was putting the set back together.The sales consultant attempted to unbend it and it broke.There was no patient involvement.This complaint involves one (1) device.This is 1 of 1 for report (b)(4).
Additional 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.Part: 03.127.006.Lot: 8254830.Manufacturing site: bettlach.Release to warehouse date: 27.March 2013.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: upon visual inspection, the handle was received separated from the sleeve.It was observed that the weld around the sleeve was cracked/fractured.Hence the complaint is confirmed.Dimensional inspection: since the complaint condition involved a cracked weld, a relevant dimensional inspection could not be performed.Conclusion: the complaint is conformed for broken condition.While no definitive root cause could be determined, it is possible that the device encountered unintended forces or excessive bending/torsional forces at the weld leading to the breakage.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.

• Brand Name: PROTECTION SLEEVE FOR 2.8MM VA DRILL GUIDE - LONG
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9268134
• Report Number: 2939274-2019-61913
• Device Sequence Number: 19300977
• Product Code: FZX
• UDI-Device Identifier: 10886982075062
• UDI-Public: (01)10886982075062
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.127.006
• Device Catalogue Number: 03.127.006
• Device Lot Number: 8254830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Received by Manufacturer: 10/17/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1