MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.4MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 12MM; BONE PLATE

Catalog Number 04.503.442.01C

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: during an interruptive hemimandibulectomy revision surgery on a (b)(6) patient, the surgeon observed an unjustified alteration of the matrix mandible screw head with regards to the screwing mode.The screw was changed.A 20 minute surgical delay was reported.This complaint (b)(4) originally intra operative event while complaint (b)(4) captures the postoperative event concomitant device reported: unknown screwdriver (part#unknown, lot#unknown, quantity 1).This complaint involves one (1) device.This report is 1 of 1 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.The screw-head is slightly deformed and the screw-recess is badly damaged.Moreover, we found several mechanical damages at the threaded shaft.Overall, the anodized layer is partially disappeared at all damaged areas.All features related to the reported complaint condition were reviewed and no other issues were identified.Dimensional analysis is not appropriate, since all complaint-relevant dimensions can no longer correspond to the valid technical drawings specifications due to the damage incurred.It was determined that based on the visual inspection results, the damage incurred was clearly caused post manufacturing.Our investigation has shown that the complaint condition is confirmed as the device was found bent and damaged.Because of the damage and the missing broken part, it is not possible to measure the relevant dimensions anymore.However, because of the damage found at the screw recess, e.G.Stripped/worn, we likely assume that a wrong screwdriver/ instrument was used during procedure.By this, the screw encountered unintended forces, e.G.Over-torque, which finally could have resulted in the damage of the screw-head.Based on the findings above a manufacturing related issue can be excluded and hence we conclude that the cause of failure is not due to any manufacturing non-conformance's.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.

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.

• Brand Name: 2.4MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 12MM
• Type of Device: BONE PLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8851649
• MDR Text Key: 152970022
• Report Number: 8030965-2019-66733
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819930063
• UDI-Public: (01)07611819930063
• Combination Product (y/n): N
• PMA/PMN Number: K063790
• 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: 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.503.442.01C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Initial Date Manufacturer Received: 07/05/2019
• Initial Date FDA Received: 08/01/2019
• Supplement Dates Manufacturer Received: 08/06/2019; 09/12/2019
• Supplement Dates FDA Received: 09/05/2019; 09/30/2019
• Patient Sequence Number: 1
• Patient Age: 24 YR