MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH COUNTERSINK W/CENTERING PINS F/1.5MM, 2.0MM & 2.7MM SCREWS; DRIVER,WIRE,BONE DRILL MANUAL

Catalog Number 310.810

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/01/2018

Event Type  Injury  

Manufacturer Narrative

This patient information is unknown.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(510k): device is not distributed in the united states, but is similar to device marketed in the usa.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 europe reports an event in (b)(6) as follows: it was reported that during jaw osteosynthesis surgery with unilock system on (b)(6) 2018, during the perforation with 1.5 x 12mm drill, the center-pin broke and remained in the patient.The surgery was successfully completed without further issue.It is unknown if there was a surgical delay.Patient outcome is unknown.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.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.This supplement 1 was inadvertently submitted with an extra digit in the mfr number.Resending supplemental information with correct follow up report number and mfr number.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

It was further reported that a new unknown drill bit was used to complete the procedure.There is no further information available.

• Brand Name: COUNTERSINK W/CENTERING PINS F/1.5MM, 2.0MM & 2.7MM SCREWS
• Type of Device: DRIVER,WIRE,BONE DRILL MANUAL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7710963
• MDR Text Key: 114730397
• Report Number: 8030965-2018-55213
• Device Sequence Number: 1
• Product Code: DZJ
• UDI-Device Identifier: 07611819019218
• UDI-Public: (01)07611819019218
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 07/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 310.810
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention