MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREW STEP DRILL GAMMA3® Ø10.5X495 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 13200190

Device Problems Break (1069); Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 10/17/2022

Event Type  malfunction  

Event Description

It was reported that during an intervention, an auger nail broke in the patient.Additionally, a 2 hour surgical delay was reported and all debris was removed from the patient.

Manufacturer Narrative

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

Manufacturer Narrative

The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received drill shows signs of long and intense usage.The drill was found to be broken from the tip region just where the step ends.The tip of the drill appeared to be in severely deformed state and spit from two sides.Material chip-off could also be observed at the free end of the tip.The flutes were found to be blunt.The breakage surface reveals a combination of both ductile & brittle fracture due to torsional and bending overload.Permanent deformation can be seen along the edges of the step from where the tip broke off.The step also showed uniform circular marks indicating towards interaction with something under rotation.It can be said that blunt flutes had a vital role in the failure, as it requires more force to cut through with blunt flutes.All these signs are evident enough to suggest that there was an intense and abnormal usage of the drill to an extent of deformation and ultimate forced fracture.Dimensional inspection indicates that the device is within the specifications.Furthermore, a hardness test according to (b)(6) on the returned item indicates the material being in accordance with the values in the material specification.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation, the root cause was attributed to a user related issue.The drill was found to be worn-off with blunt cutting edges.Significant signs were observed indicating towards an intense usage.Consequently, the drill broke due to torsional and bending overload.Since the device was manufactured in 2012 (10 years ago), a weakened structural integrity over years of usage and reprocessing is deemed plausible.If any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that during an intervention, an auger nail broke in the patient.Additionally, a 2 hour surgical delay was reported and all debris was removed from the patient.

• Brand Name: LAG SCREW STEP DRILL GAMMA3® Ø10.5X495 MM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15778998
• MDR Text Key: 307288547
• Report Number: 0009610622-2022-00500
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 13200190
• Device Lot Number: K753025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2012
• 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