MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 8.5MM/2.8MM WIRE SLEEVE; MISC ORTHO SURGICAL INSTR

Model Number	312.08
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.Part: 312.08, lot: 3121840, manufacturing site: (b)(4), release to warehouse date: march 26 2009.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.Visual inspection: the 8.5mm/2.8mm wire sleeve was received showing the teeth of the distal tip bent outwards.The tips/edges of the teeth are bent outwards.Due to the deformation, the wire sleeve may not securely sit into bone.Dimensional inspection: dimensional inspection of the distal tip could not be conducted due to post manufacturing damage.Document/specification review: the following drawings, reflecting the manufactured and current revision, were reviewed.8.5mm/2.8mm wire sleeve.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Conclusion: the complaint condition is confirmed for the 8.5mm/2.8mm wire sleeve as the tips/edges of the teeth are bent outwards.Due to the deformation, the wire sleeve may not securely sit into bone.No definitive root cause could be determined.It is possible that the wire sleeve encountered unintended/excessive forces, dense bone, and/or rough handling during device use.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.
Event or Problem Description
It was reported that on an unknown date, a wire sleeve from a headless compression screw loaner set was found to be unfit for surgical use during a routine inspection.There was no patient and procedure impact reported.Upon manufacturer receipt and investigation the device was found to be bend.This complaint involves one (1) 8.5mm/2.8mm wire sleeve.This report is 1 of 1 for (b)(4).

• Brand Name: 8.5MM/2.8MM WIRE SLEEVE
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9158396
• Report Number: 2939274-2019-61211
• Device Sequence Number: 2230397
• Product Code: LHX
• UDI-Device Identifier: 10886982187581
• UDI-Public: (01)10886982187581
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 08/15/2019

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: 312.08
• Device Catalogue Number: 312.08
• Device Lot Number: 3121840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1