MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH DHS®/DCS® COUPLING SCREW; EXTRACTOR

Catalog Number 338.310

Device Problem Bent (1059)

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

Event Date 04/24/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown.Lot number is unknown.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter email address and phone number are unavailable.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 the (b)(6) as follows: it was reported that the surgeon tried to insert the dynamic hip screw (dhs) through the correct dhr plate.The screw became stuck in the plate and would not advance further.The surgeon managed to remove the screw from the patient and changed to a new screw with the same size which worked fine.On visualization, both the screw and the connection instrument were slightly bent.The surgeon also complained that a 4.5mm cortex screw used in the plate bent on implantation; this screw was also removed.Concomitant devices: dhs/dcs plate (part/lot number: unknown, quantity: 1).This report is for a dhs®/dcs® coupling screw.This is report 3 of 3 for (b)(4).

Manufacturer Narrative

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

No patient harm was reported.Procedure was completed successfully with no surgical delay reported.

Manufacturer Narrative

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: DHS®/DCS® COUPLING SCREW
• Type of Device: EXTRACTOR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7515804
• MDR Text Key: 108357835
• Report Number: 8030965-2018-53775
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 07611819004672
• UDI-Public: (01)07611819004672
• 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: 04/25/2018

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: 338.310
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/25/2018
• Initial Date FDA Received: 05/15/2018
• Supplement Dates Manufacturer Received: 05/16/2018; 06/29/2018
• Supplement Dates FDA Received: 06/05/2018; 06/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1