MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM LCP® PROXIMAL FEMUR HOOK PLATE 12 HOLES/313MM; PLATE, FIXATION, BONE

Model Number	242.125
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: patient identifier, date of birth, and weight not available for reporting.Date of device breakage is not known.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 patient was originally implanted with the 4.5mm locking compression plate (lcp) proximal femur hook plate on (b)(6) 2018.Although patient was instructed ¿no weight bearing¿, patient did walk with weight bearing and the plate broke.Patient was returned to surgery on (b)(6) 2018 where surgeon removed the broken plate without difficulty.Patient was revised to another plate.Surgery was completed successfully with no additional medical intervention required.Patient reported as stable following surgery.This report is for one (1) 4.5mm lcp proximal femur hook plate.(b)(4).
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.A device history record (dhr) review was performed for part number: 242.125, lot number: h465519, part mfg date: 09-oct-2017, part exp.Date: n/a, manufacturing location: (b)(6): no non-conformance reports (ncrs) were generated during production.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 4.5mm proximal femur plates was processed through the normal manufacturing and inspection operations with no non-conformance noted.This 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.The 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
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: 4.5MM LCP® PROXIMAL FEMUR HOOK PLATE 12 HOLES/313MM
• 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: 7346572
• Report Number: 2939274-2018-51097
• Device Sequence Number: 19180787
• Product Code: HRS
• UDI-Device Identifier: 10886982168160
• UDI-Public: (01)10886982168160(10)H465519
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K032032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 242.125
• Device Catalogue Number: 242.125
• Device Lot Number: H465519
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2018
• Supplement Date Received by Manufacturer: 04/20/2018; 04/20/2018
• Initial Report FDA Received Date: 03/16/2018
• Supplement Report FDA Received Date: 04/20/2018; 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR