MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM BROAD LCP PLATE 10 HOLES/188MM; PLATE, FIXATION, BONE

Catalog Number 226.601

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Additional product code: hwc, ktt.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Occupation: reporter is a j&j employee.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that, patient underwent revision surgery for the left femur fracture.A ten (10) hole locking compression plate (lcp), eight (8) locking screws and two (2) cortical screws were removed due to the plate breaking.It was noted this is the second plate to fail the patient; the first plate was not a synthes plate.The revision procedure was performed effectively without any complications.This report is for one (1) 4.5mm broad lcp plate 10 holes/188mm.This is report 1 of 1 for complaint (b)(4).

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.H3, h4, h6: part number: 226.601, lot number: l003433, part manufacture date: 27 may 2016, manufacturing location: grenchen, no ncr's were generated during production.A review of the device history record could not be performed as the product was not returned and the lot number provided does not match the part number.Visual inspection: the lcp 4.5/5 broad 10ho l188 sst (p/n: 226.601, lot number: l003433) was received at us customer quality (cq).Visual inspection of the complaint device showed the plate had broken at the 5th hole.Device failure/defect identified? yes.Dimensional inspection: a dimensional inspection was not performed due to post-manufacturing damage.Document/specification review: current and manufactured was reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the plate had broken at the 5th hole.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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 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.

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.H6: a review of the device history record could not be performed as the product was not returned and the lot number provided does not match the part number.Customer quality investigation: the implant(s) was not returned, and the investigation will be completed based on the received image(s).The image(s) was reviewed, and the complaint condition(s) of broken was confirmed as the image(s) provided showed the plate broke inside the patient.As the implant(s) was not returned, an as received, dimensional, material or drawing reviews are not applicable.Conclusion: there is no indication that a design or manufacturing issue contributed to the complaint as the circumstances during the time of the event are unknown.No new malfunctions were observed during this investigation (based on the images) that may have contributed to the complaint condition.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 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 BROAD LCP PLATE 10 HOLES/188MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11601727
• MDR Text Key: 260573674
• Report Number: 8030965-2021-02459
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819242067
• UDI-Public: (01)07611819242067
• Combination Product (y/n): N
• PMA/PMN Number: K082807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 226.601
• Device Lot Number: L003433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Date Manufacturer Received: 06/03/2021
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: CORTEX; UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR