MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.2MM TROCAR FOR RECON LOCKING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	03.010.077
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.The device has been 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, during a routine incoming inspection of a loaner set at the field service location, it was observed that the trocar was bent.There was no known patient or hospital involvement.This report involves one (1) 3.2mm trocar for recon locking.This is report 1 of 1 for (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, h6: part number:03.010.077, synthes lot number: pe00846, supplier lot number: n/a, release to warehouse date: december 14, 2010, expiration date: n/a, supplier: (b)(4).No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Visual inspection: 3.2mm trocar for recon locking (part# 03.010.077, lot# pe00846, qty# 1) was returned and received at us customer quality (cq).Upon visual inspection at cq, it is observed that the shaft of the device was slightly bent.Rest of the device shows normal wear consistent with the device use which would not contribute to the complaint condition.Thus, the complaint is being confirmed.Device failure / defect identified? yes.Dimensional inspection (calipers: ca215p): dimensional inspection of the received device was performed at cq.The diameter of the shaft of the device was intended to be measuring from 3.0 mm to 3.2 mm and was measured to be within specification.Document/specification review: based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed.3.2mm trocar lateral entry femoral nail.Complaint confirmed? yes.Investigation conclusion: the complaint condition is being confirmed for 3.2mm trocar for recon locking (part# 03.010.077, lot# pe00846) as the shaft of the device was slightly bent.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces on the device.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 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: 3.2MM TROCAR FOR RECON LOCKING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11322398
• Report Number: 2939274-2021-00833
• Device Sequence Number: 4139966
• Product Code: LXH
• UDI-Device Identifier: 10886982067470
• UDI-Public: (01)10886982067470
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021

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: PE00846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1