MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.2MM TROCAR FOR RECON LOCKING; MISC ORTHO SURGICAL INSTR

Model Number	03.010.077
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device deemed reportable at conclusion of investigation.Investigation summary: visual inspection: the 3.2mm trocar for recon locking (p/n: 03.010.077, lot number: pe00159) was received at us cq.Visual inspection of the complaint device showed that the device was bent more than the specified 2mm and in another axis.Device failure/defect identified? yes.Dimensional inspection: specified dimensions: shaft od = 3.1 +/- 0.1mm.Measured dimensions: shaft od = 3.09mm, conforming.Document/specification review: document was reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the device is bent more than specified and in another axis as well.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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: part #: 03.010.077, synthes lot number: pe00159, supplier lot number: pe00159, release to warehouse date: 21-jul-2009, supplier: (b)(4).Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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 on an unknown date, one helical blade (1) one (1) locking bolt measuring device, and one (1) trocar did not function, and the one (1) radiolucent aiming arm for retrograde standard locking was broken.All of the device issues were noticed during the reverse logistics audit of returned devices.There was no patient involvement and no additional information is available.This is report 2 of 2 for (b)(4).

• Brand Name: 3.2MM TROCAR FOR RECON LOCKING
• 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: 10282685
• Report Number: 2939274-2020-03223
• Device Sequence Number: 10891575
• Product Code: LXH
• UDI-Device Identifier: 10886982067470
• UDI-Public: (01)10886982067470
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2020

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: 03.010.077
• Device Catalogue Number: 03.010.077
• Device Lot Number: PE00159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 07/16/2020
• Patient Sequence Number: 1