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

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Patient Involvement (2645)

Event Date 03/03/2019

Event Type  malfunction  

Manufacturer Narrative

This report is for an unknown nail insertion handles/unknown lot.Part and lot number are unknown; udi number is unknown.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 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 reported that on (b)(6) 2019, during a proximal femoral nail antirotation case, an unknown insertion handle got stuck in the protection sleeve and would not release.The protection sleeve and buttress/compression nut were damage to release the device, which now will not separate.A pfna blade perforated was damaged.It was badly scratched from the removal process after it got stuck and discarded being replaced with the same size blade.The procedure was completed successfully with a surgical delay of 15 minutes.The patient consequence was unknown.This complaint involves three (3) devices.This report is for one (1) nail insertion handles.This report is 3 of 3 for (b)(4).

• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 8461942
• MDR Text Key: 140302603
• Report Number: 8030965-2019-62326
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1