MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREWDRIVER GAMMA3® 380X110MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 13200200

Device Problems Bent (1059); Break (1069); Difficult to Remove (1528)

Patient Problem Tooth Fracture (2428)

Event Date 10/20/2017

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed, any additional information will be reported in a supplemental report.

Event Description

During gamma nail extraction (patient choice), a tooth on the lag screw driver 1320-0200 bent during attempt to remove the lag screw.Physician tried to bend it back with surgical plier.The bent tooth broke off.Physician stated there was bone growth over the lag screw making it more difficult to engage the lag screw driver into the lag screw.After the tooth broke off the physician was still able to remove the lag screw and the rest of the gamma nail without any complications.

Manufacturer Narrative

Product inquiry states the lag screwdriver gamma3® 380x110mm to be the subject product.No further associated product was reported.A review of the dhr revealed no discrepancies.The reported event that the lag screwdriver was alleged of issue instruments - lag screwdriver, broken, worn or deformed pegs could be confirmed as the device was returned for evaluation and matches the reported failure.Visual inspection of the provided lag screwdriver of the gamma3 system show signs of usage.All teeth of the screwdriver tip are worn and deformed; one of them is broken off completely.Several scratches and dents were observed on the handle of the screwdriver as well.The inner rod of the screwdriver and the compression wheel could be disassembled.Based on investigation, this breakage could be user related and could have been caused by application of too high force while removing the lag screw, improper handling and is not manufacturer related.During investigation no material, dimensional, functional, visual or manufacturing related issues were found.Review of complaint history, capa databases and risk analysis did not identify any discrepancies.The review of the risk assessment for the failure mode indicated the issue was addressed adequately.There are no open actions in place related to the reported event for the subject product.No non-conformity was identified.If any further information is provided, the investigation report will be updated.

Event Description

During gamma nail extraction (patient choice), a tooth on the lag screw driver 1320-0200 bent during attempt to remove the lag screw.Physician tried to bend it back with surgical plier.The bent tooth broke off.Physician stated there was bone growth over the lag screw making it more difficult to engage the lag screw driver into the lag screw.After the tooth broke off the physician was still able to remove the lag screw and the rest of the gamma nail without any complications.

• Brand Name: LAG SCREWDRIVER GAMMA3® 380X110MM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7040923
• MDR Text Key: 93206874
• Report Number: 0009610622-2017-00354
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/02/2018

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: 13200200
• Device Lot Number: 303290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/20/2017
• Initial Date FDA Received: 11/17/2017
• Supplement Dates Manufacturer Received: 03/06/2018
• Supplement Dates FDA Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other