MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.5MM LCP® PROXIMAL FEMUR PLATE 4 HOLES/175MM-LEFT; PLATE, FIXATION, BONE

Model Number	242.104
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient¿s height reported as 175 cms.This patient information is unknown.Date of postoperative plate breakage is unknown.Additional device code: hwc complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested and is currently pending completion.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
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the patient underwent an osteosynthesis surgery on (b)(6) 2017 to treat the left proximal femur fracture.On (b)(6) 2018 the patient underwent a removal of a locking compression plate (lcp), (4) cortical screws and (2) locking screws due to postoperative plate breakage.The patient had pseudarthrosis that caused the plate to be broken.There were no fragments generated from the broken device.There was no surgical delay.The plate and (6) screws were removed and replaced for a longer plate, and the procedure was successfully completed.Patient outcome was not reported.Concomitant devices reported: unknown cortical screws 4.5mm (product# unknown, lot# unknown, quantity 4); unknown locking screws 7.3mm (product# unknown, lot# unknown, quantity 2).This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Flow: broken.Visual inspection: the photo of the broken 4.5 mm lcp proximal femur plate was received at us cq.The x-ray shows a break on the femur plate.According to the product drawing and the x-ray, the plate broke at the 3rd hole that is proximal to the femoral head.This agrees with the reported complaint condition, thus confirming the complaint.Dimensional inspection: dimensional analysis was not performed as the plate was not returned.Document/specification review: the following drawing(s) was reviewed; - lcp proximal femur plate left 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 nonconformance 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.Risk analysis was performed.Conclusion: the complaint condition is confirmed as the femur plate x-ray showed a broken plate.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.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.Device history record (dhr) review: part number: 242.104; lot number: 9845562; part manufacture date: 09-jul-2015; manufacturing location: elmira; part expiration date: n/a; nonconformance 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 lcp proximal femur plate 4 holes/175mm-left product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities 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 nonconformance 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.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.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 PLATE 4 HOLES/175MM-LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7739403
• Report Number: 8030965-2018-55410
• Device Sequence Number: 13624171
• Product Code: HRS
• UDI-Device Identifier: 10886982167927
• UDI-Public: (01)10886982167927
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K030858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/11/2018

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: 242.104
• Device Catalogue Number: 242.104
• Device Lot Number: 9845562
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 07/11/2018; 10/01/2018; 10/05/2018
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 08/01/2018; 10/02/2018; 10/05/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 86