MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM UNIVERSAL DRILL GUIDE

Model Number	323.201
Medical Device Problem Codes	Component Missing (2306); Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is j&j employee.A product investigation was conducted.Visual inspection: the 2.0 mm universal (p/n: 323.201, lot#: l861355) was returned and received at us cq.Upon visual inspection, it was observed that the spring and sleeve were missing and the fixed sleeve is deformed.No other issues were identified with the returned components of the device.Service & repair evaluation: the customer reported the universal drill guide was missing a piece.The repair technician reported the device was missing the spring, sleeve, and head and the fixed sleeve was damaged.Damaged component 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.Document/specification review: based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed investigation conclusion: the complaint condition is confirmed for the 2.0 mm universal (p/n: 323.201, lot#: l861355).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 due to device use and sterilization.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.A device history record (dhr) review was conducted: part: 323.201, lot: l861355, manufacturing site: (b)(4), release to warehouse date: 19.Jun.2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's 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.
Event or Problem Description
It was reported that during an incoming routine inspection of a loaner set on an unknown date, a universal drill guide was noted to have a missing piece.There was no patient involvement.During manufacturer's investigation on (b)(6) 2020 of the returned device, it was identified that the spring and sleeve were missing and the fixed sleeve is deformed.This is report 1 of 1 for (b)(4).

• Brand Name: 2.0MM UNIVERSAL DRILL GUIDE
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9577171
• Report Number: 2939274-2020-00131
• Device Sequence Number: 14076147
• Product Code: FZX
• UDI-Device Identifier: 10886982190772
• UDI-Public: (01)10886982190772
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Type of Report: Initial
• Report Date (Section B): 11/13/2019

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: 323.201
• Device Catalogue Number: 323.201
• Device Lot Number: L861355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/02/2020
• Initial Report FDA Received Date: 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1