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 jnj 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 or Problem Description
It was reported that on an unknown date, the protection sleeve for drill guide was broken in the field.And as confirmed by the reporter, it was found broken when they opened the set.There was no patient involvement.This complaint involves one (1) device.This report involves one (1) protection sleeve for 2.8mm va drill guide - long.This is report 1 of 1 (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.H3, h4, h6- the protection sleeve for 2.8mm va drill guide ¿ long (part #: 03.127.006 and lot #: 8360618) was received at us cq.Upon visual inspection, the device was found to be broken at the weld point between the handle and sleeve.No other issues were identified.The complaint condition is confirmed as the handle at the weld was broken off from the sleeve shaft.There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.The potential cause could be that the device encountered unintended forces or excessive bending/torsional forces at the weld leading to the breakage.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: 03.127.006, lot: 8360618, manufacturing site: bettlach, release to warehouse date: 17.Jun.2013.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: 10445103
• Report Number: 2939274-2020-03762
• Device Sequence Number: 14066545
• Product Code: FZX
• UDI-Device Identifier: 10886982075062
• UDI-Public: (01)10886982075062
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2020

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: 8360618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 09/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1