MAUDE Adverse Event Report: SYNTHES GMBH TOMOFIXTIBHEADPL ANATOM MED PROX LE HE 4; PLATE,FIXATION,BONE

Catalog Number	440.837S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 left-sided tomofix anatomical plate was broken.The patient initially had a left-sided tomofix hto surgery, the lateral cortex was cracked and a left-sided tomofix anatomical plate was implanted.Patient was non-compliant with post-operative instructions and began fully weight bearin 2 weeks post-surgery.Patient attended a follow-up appointment 2 months after the initial surgery and x-rays revealed the plate had broken thru one of the proximal screw holes.The patient underwent revision surgery and a standard tomofix hto plate was implanted.This report is for one (1) tomofixtibheadpl anatom med prox le he 4.This is report 1 of 1 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.Part: 440.837s.Lot: 78p9339.Manufacturing site: (b)(4).Release to warehouse date: december 3, 2020.Expire date: november 1, 2030.A manufacturing record evaluation was performed for the finished device 440.837s, lot: 78p9339 and no non-conformances were identified.Visual inspection: the complaint device tomofix tibial head plate (product code: 440.837s, lot number: 78p9339) was returned to customer quality (cq) west chester for investigation along with the implanted screw as concomitant device with no reported issues.The tomofix plate had broken off near the head of the plate.The plate also had severe scratches which could have happened during implantation.X-rays provided for investigation were reviewed and the findings confirms the complaint issue.Device/defect identified: yes.Document /specification review: based on the date of manufacture, current and manufactured revision of drawings were reviewed.Tomofix anat.Med.Prox.Right lef.Dimensional inspection: complaint relevant dimension cannot be measured due to the design of the device.Complaint confirmed: complaint can be confirmed based on the available information.Conclusion: the plate had broken after implantation.A definitive root cause was not determined during investigation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.

• Brand Name: TOMOFIXTIBHEADPL ANATOM MED PROX LE HE 4
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK RARON (CH); kanalstrasse west 30; raron 3942 ; SZ 3942
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12937162
• Report Number: 8030965-2021-09976
• Device Sequence Number: 14230111
• Product Code: HRS
• UDI-Device Identifier: 07612334080240
• UDI-Public: (01)07612334080240
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2021

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 Catalogue Number: 440.837S
• Device Lot Number: 78P9339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2021
• Supplement Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: TRAUMA.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 97 KG