MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CAM LOCK LEVER FOR RADIOLUCENT AIMING ARMS; GUIDE

Model Number	03.010.497
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was 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, a radiolucent aiming arm was received with a broken trocar locking clip and was not available to be used in surgery.There was no patient involvement.This complaint involves (2) devices.This report is for one (1) cam lock lever for radiolucent aiming arms.This is report 2 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: a product investigation was conducted.Visual inspection: the cam lock lever for radiolucent aiming arms (part # 03.010.497, lot # t170202, mfg # 10-oct-2018) was received at us cq with the lever broken off from the aiming arm (03.033.003; lot l971745), a portion of the cam lock lever is still attached to the aiming arm.This is consistent with the reported complaint condition, thus confirming the complaint.The aiming arm itself showed no signs of breakage or other damage or defect.Dimensional inspection: dimensional analysis was not performed as relevant features are significantly deformed.Document/specification review: the following drawing(s) was reviewed; cam lock for radiolucent aiming arm ex nail instrument expert.Conclusion: there is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.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.H3, h4, h6: a device history record (dhr) review was conducted: part number: 03.010.497; lot number: t170202; manufacturing site: tuttlingen; release to warehouse date: 10-oct-2018.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.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: CAM LOCK LEVER FOR RADIOLUCENT AIMING ARMS
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9225928
• Report Number: 2939274-2019-61719
• Device Sequence Number: 2509871
• Product Code: FZX
• UDI-Device Identifier: 10886982069146
• UDI-Public: (01)10886982069146
• 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,Followup
• Report Date (Section B): 10/08/2019

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: 03.010.497
• Device Catalogue Number: 03.010.497
• Device Lot Number: T170202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 11/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1