MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC AIMING ARM FOR ANTEGRADE STD LOCKING; GUIDE

Model Number	03.010.049
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received.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 (b)(6) 2021, the patient underwent for a surgery.During the surgery, while dynamic drilling of the hole, the fluted drill bit contacted titanium cannulated retrograde/antegrade femoral nail.There was no surgical delay.The procedure was successfully completed.The patient outcome was unknown.This complaint involves three (3) devices.This report is for (1) aiming arm for antegrade std locking.This report is 1 of 3 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.H3, h4, h6: part 03.010.049, lot 8890619: release to warehouse date: may 06, 2014.Manufacturer: hagendorf.No non-conformance repots (ncr's) were generated during production.H3, h6: a product investigation was completed: visual inspection of the complaint device showed few nicks and scratches on the surface of the aiming arm.A functional assessment was not performed with the complaint device since the applicable mating component(s) were not returned.No dimensional inspection was performed as there was no damage.The current and manufactured to drawings were reviewed; no design issues or discrepancies were identified.This complaint is not confirmed as no defect was observed that could impact the functionality of the device; however scratches and nicks were observed.No root cause could definitively be determined for the reported complaint condition.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 preventive 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: AIMING ARM FOR ANTEGRADE STD LOCKING
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12086834
• Report Number: 2939274-2021-03294
• Device Sequence Number: 3662936
• Product Code: FZX
• UDI-Device Identifier: 10886982067210
• UDI-Public: (01)10886982067210
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2021

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: 03.010.049
• Device Catalogue Number: 03.010.049
• Device Lot Number: 8890619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 07/29/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10 TI CANN RETRO/ANTEGRADE FEM NL/360-S; 4.2 3-FLTD DRILL BIT QC/330/100 CALIB; 10 TI CANN RETRO/ANTEGRADE FEM NL/360-S; 4.2 3-FLTD DRILL BIT QC/330/100 CALIB
• Patient Age: 20 YR