MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.6 THREADED GUIDE WIRE TROCAR POINT 220; SCREW, FIXATION, BONE

Model Number	02.226.000
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 was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 the loaner set it was observed that the threaded guide wire trocar was bent.There was no patient involvement.This report is for (1) 1.6 threaded guide wire trocar point 220.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.Visual inspection: the 1.6 threaded guide wire trocar point 220 (p/n: 02.226.000, lot number: 7667199) was received at us cq.Visual inspection of the complaint device showed the device was received bent.No other issues were identified with the returned device.Dimensional inspection: drawing: se_406008 rev a.Feature: shaft diameter.Specification: 1.6 mm 0/-0.1 mm.Measured dimension: 1.58 mm.Result: conforming.Measurement device: caliper ca592.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Se_406008 rev b/a (current/manufactured).No design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the received bent.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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 lot - a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances 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.

• Brand Name: 1.6 THREADED GUIDE WIRE TROCAR POINT 220
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12528343
• Report Number: 2939274-2021-05750
• Device Sequence Number: 11593638
• Product Code: HWC
• UDI-Device Identifier: 10886982057631
• UDI-Public: 10886982057631
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K080943
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2021

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: 02.226.000
• Device Catalogue Number: 02.226.000
• Device Lot Number: 7667199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 10/05/2021
• Patient Sequence Number: 1