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

Model Number	03.211.002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is company representative.Investigation summary: the 2.0 mm universal variable angle locking drill guide (p/n 03.211.002, lot # 8196784) was received showing one of the prongs/teeth on the variable angle (va) tip broken off, and the broken off fragment was not returned and is missing.The remaining prongs were observed to be slightly bent and the cannulation through the va hole was deformed.The orange epoxy color code was also observed to be peeled off and missing.The device failures/defects of broken, deformed, and missing color marking were identified during the investigation.Dimensional inspection was not conducted due to the broken and deformed va tip/hole and missing fragments.The visual appearance issue of missing color markings is conclusive.Document/specification review: drawings, reflecting the manufactured and current revision, were reviewed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The complaint condition is confirmed for the 2.0 mm universal variable angle locking drill guide (p/n 03.211.002, lot # 8196784) as one of the prongs/teeth on the va tip was broken off, and the broken off fragment was not returned and is missing.The remaining prongs were observed to be slightly bent and the cannulation through the va tip/hole was deformed.The orange epoxy color code was also observed to be peeled off and missing.While no definitive root cause could be determined, it is possible that the va tip/hole was deformed and the prong was broken due to unintended forces/rough handling from device use of the operator.The missing epoxy color code was likely peeled/fallen off due to consistent use and reprocessing over the part¿s lifetime (6+ years).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 history review: part: 03.211.002, lot: 8196784, manufacturing site: (b)(4), release to warehouse date: 03 jan 2013.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 on (b)(6) 2019, during elbow surgery one of the teeth on the 2.0 mm universal variable angle locking guide for the 2.7 mm locking screws broke during the procedure.The metal piece was retrieved and the procedure continued.Fragments were generated from a broken device and removed easily without additional intervention.There was no surgical delay reported.Procedure was successfully completed.Patient outcome was unknown.Concomitant devices reported: unknown locking screws (part # unknown, lot # unknown, quantity# unknown).This is report 1 of 1 for (b)(4).

• Brand Name: 2.0MM UNIVERSAL VARIABLE ANGLE LOCKING 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: 8888738
• Report Number: 2939274-2019-59802
• Device Sequence Number: 14222885
• Product Code: FZX
• UDI-Device Identifier: 10886982076007
• UDI-Public: (01)10886982076007
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 07/18/2019

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: 03.211.002
• Device Catalogue Number: 03.211.002
• Device Lot Number: 8196784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Weight: 77