MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/60MM; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Model Number 02.231.260

Device Problems Device Slipped (1584); Device-Device Incompatibility (2919)

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

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes 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.(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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 that the patient underwent the removal of osteosynthesis material and a condylar support plate that had failed.The distal locking screws of the plate were loose and one was already exposed outside of the skin.An additional reduction was performed but the screws did not block the plate and it was decided to remove all the material and put a splint in one of the wounds that was found to be infected.The first intervention was performed because the distal screws of the plate came off.The second operation was performed to extract a screw that was exposed through the skin and the third intervention was when all of the material was removed.The first two interventions were performed to remove the implant and try to correct the new fracture, in the last surgery it was shown that there was an infection.This report is for one (1) 5.0mm variable angle lockng screw/slf-tpng/strdrv/60mm.This is report 4 of 9 for (b)(4).This report is linked to (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 investigation summary product was not returned.Based on the information available, it has been determined that no corrective and 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 history part/lot combination are unknown at synthes gmbh, no dhr review possible.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: 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/60MM
• Type of Device: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10312728
• MDR Text Key: 200012905
• Report Number: 8030965-2020-05184
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982062192
• UDI-Public: 10886982062192
• Combination Product (y/n): N
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.231.260
• Device Catalogue Number: 02.231.260
• Device Lot Number: 31P1248
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention