MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 95 DEG CONDYLAR PLATE 9 HOLES/80MM/156MM; APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT

Catalog Number 237.960

Device Problem Crack (1135)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.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.(b)(4).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 on (b)(6) 2020, that a revision surgery for the removal of an angle blade plate and seven (7) screws was performed.The angle blade plate had developed a crack approximately one (1) centimeter from the 90 degree bend.The crack was due to too much of a load on the implant which resulted in the implant failing and an infected non-union.The angle blade plate and screws were completely and easily removed.The angle blade plate was a nine (9) hole plate, and seven (7) screws were used.No fragments were generated.Patient outcome is unknown.The primary surgery was performed (b)(6) 2010, concomitant devices reported: screws: trauma (part number unknown, lot unknown, quantity 7).This report involves one (1) 95 deg condylar plate 9 holes/80mm/156mm.This is report 1 of 8 for (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.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

Product complaint # (b)(4).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, h6: investigation summary: complained issue could not be replicated and/or confirmed (plate cracked) based on the available information (incl.Pictures and/or x-ray¿s).Product was not returned therefore no further investigation possible.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 (information or/and material), 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.

• Brand Name: 95 DEG CONDYLAR PLATE 9 HOLES/80MM/156MM
• Type of Device: APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9945472
• MDR Text Key: 193622729
• Report Number: 8030965-2020-02775
• Device Sequence Number: 1
• Product Code: KTW
• UDI-Device Identifier: 07611819006928
• UDI-Public: (01)07611819006928
• Combination Product (y/n): N
• PMA/PMN Number: K914546
• 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: 03/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 237.960
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2020
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention