MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM BROAD LCP® PLATE 7 HOLES/134MM; PLATE,FIXATION,BONE

Model Number	226.571
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional pro codes: hwc.Ktt.(b)(4).The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.
Event or Problem Description
It was reported that the patient underwent revision surgery and total femoral replacement due to a failed total knee arthroplasty which required a tumor resection on (b)(6) 2019.Originally the patient was implanted on (b)(6) 2016.On (b)(6) 2019, the patient reported difficulty bearing weight on left leg and was diagnosed with a left femur lytic lesion.There was no reported surgical delay.The procedure was completed successfully.Patient outcome is unknown.This complaint involves an unknown number of devices.This complaint involves one (1) device.This report is for one (1) 4.5 mm broad lcp® plate 7 holes/134 mm.This is report 1 of 8 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.Investigation flow: visual.Visual inspection: 4.5mm broad lcp® plate 7 holes/134mm was received at cq (quantity 1 part# 226.571 lot#4949119).Upon visual inspection at cq, it is observed that the device does not have any defects.But the reported complaint is not confirmed for the adverse event.Since no x-ray/ct scan was provided.Does the received condition agree with the complaint description? no.Was the complaint confirmed? no.Document/ specification review: design drawing from date of manufacture to current were reviewed during this investigation and no design issues were identified.Dimensional analysis: a dimensional inspection was not performed as no damage/breakage is found to the returned device as observed during the visual inspection.Investigation conclusion: a visual inspection, and document/specification review were performed as part of this investigation.It is observed that the device does not have any damage.But the reported complaint is not confirmed for the adverse event.Since no x-ray/ct scan was provided.A definitive root cause could not be identified.No product design or manufacturing issues were identified, and no new malfunctions were identified either.Based upon these results, 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 number: 226.571.Lot number: 4949119.Part manufacture date: mar 07, 2005.Manufacturing location: elmira.Part expiration date: n/a.Non-conformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 4.5mm broad lcp plate 7 holes/134mm product was processed through the normal manufacturing and inspection operations with no rework nor non-conformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no non-conformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.Device history review.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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.
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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.

• Brand Name: 4.5MM BROAD LCP® PLATE 7 HOLES/134MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9209945
• Report Number: 2939274-2019-61662
• Device Sequence Number: 18944654
• Product Code: HRS
• UDI-Device Identifier: 10886982159052
• UDI-Public: (01)10886982159052
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K082807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 226.571
• Device Catalogue Number: 226.571
• Device Lot Number: 4949119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 10/25/2019; 11/08/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 11/05/2019; 11/25/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 111