MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM LCP® CURVED CONDYLAR PLATE 16 HOLES/350MM-LEFT; APPLIANCE,FIXATION,NAIL

Model Number	02.001.306
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 reports an event in (b)(6) as follows: it was reported that on an unknown date, the patient underwent a distal femur fracture open reduction internal fixation (orif) procedure and was implanted with a locking compression plate (lcp) condylar plate.The lcp condylar plate developed a non-union fracture and eventually broke.It is unknown if there was a revision surgery.This report is for one (1) 4.5mm lcp® curved condylar plate 16 holes/350mm-left.This is report 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.The lcp condylar-plate 4.5/5 curv le 16 hole l350 ss (part # 02.001.306, lot # h143194, mfg # 22-jul-2016) was received with the plate broken in two pieces.This is consistent with the reported complaint condition, thus confirming the complaint.A review of the raw material device history record revealed this lot met all specifications with no non-conformance noted.Conclusion: the complaint condition is confirmed as the lcp condylar-plate (part # 02.001.306, lot # h143194) was received with the plate broken.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.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot: part number: 02.001.306, lot number: h143194, part manufacture date: 22-jul-2016, 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 curved condylar plate 16 holes/350mm-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.

• Brand Name: 4.5MM LCP® CURVED CONDYLAR PLATE 16 HOLES/350MM-LEFT
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8395138
• Report Number: 2939274-2019-56838
• Device Sequence Number: 2926611
• Product Code: KTT
• UDI-Device Identifier: 10886982027597
• UDI-Public: (01)10886982027597
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K041911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.001.306
• Device Catalogue Number: 02.001.306
• Device Lot Number: H143194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Initial Date Received by Manufacturer: 02/13/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 04/04/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention