MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CLAMPING FOOT FOR 328.040 LCP 3.5MM AND LC-DCP 3.5MM; GUIDE

Model Number	325.041
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2020
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 february 19, 2020, the clamping foot broke during open reduction internal fixation (orif) of the femur.There were no fragments generated from the broken device.There was no surgical delay.Procedure was successfully completed.Patient outcome was good.This complaint involves one (1) device.This is 1 of 1 for report (b)(4).
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: h3, h6: investigation summary investigation flow: damage visual inspection: the clamping foot for 328.040 lcp® 3.5mm and lc-dcp® 3.5mm (p/n: 325.041, lot number: 3150713) was received at us cq.Upon visual inspection, one of the retaining jaws has broken off.Device failure/defect identified? yes dimensional inspection: no dimensional inspection was performed due to post-manufacturing damage.Document/specification review: no design issues or discrepancies were identified.Complaint confirmed? yes investigation conclusion: this complaint is confirmed as one of the retaining jaws has broken off.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 lot part: 325.041 lot: 3150713 manufacturing site: hägendorf release to warehouse date: jun.18, 2009 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: CLAMPING FOOT FOR 328.040 LCP 3.5MM AND LC-DCP 3.5MM
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9844801
• Report Number: 2939274-2020-01313
• Device Sequence Number: 11470527
• Product Code: FZX
• UDI-Device Identifier: 10886982191359
• UDI-Public: (01)10886982191359
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2020

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: 325.041
• Device Catalogue Number: 325.041
• Device Lot Number: 3150713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 04/13/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CLMPNG FT FR 328.040 LCP 3.5MM N LC-DCP 3.5MM
• Patient Age: 8 YR