MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; NAIL, FIXATION, BONE

Device Problem Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/14/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown.The 510k: this report is for an unknown expert tibial nail /unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is unknown.Explant date is not applicable as product is still implanted.Complainant part is not expected to be returned for manufacturer review/investigation.Address and telephone number unknown.Without a lot number the device history records review could not be completed.The manufacture date is unknown.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 when using the supra patella nailing kit, the surgeon had a lot of difficulty removing the connecting screw from the nail.As previously suggested, the surgeon used hexagonal shaft and the wrench which are part of the instrument set as listed in the surgical technique.Eventually and with a lot of force the connecting screw disengaged.The surgery was prolonged about 10 minutes.Concomitant parts: unknown quantity of part number 357.398, lot number unknown; unknown quantity of part number 321.160, lot number unknown.This report is for one (1) unknown expert tibial nail.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Corrected data: implanted date, concomitant medical products and therapy dates, name and address.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.

Event Description

It was noted the procedure was completed successfully.

• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7498937
• MDR Text Key: 107742078
• Report Number: 8030965-2018-53643
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1