MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER BIT AXSOS T15, AO FITTING 4.0MM LOCKING SET; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 702753

Device Problems Break (1069); Device Damaged by Another Device (2915)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/07/2021

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.

Event Description

It was reported there was difficulty inserting the screw due to artificial bone obstruction.The user attempted to insert the screw by power driver, but the screwdriver bit broke.

Manufacturer Narrative

D9 / h3 was updated to indicate the device was available for return/returned.H6 method, results, conclusion code corrected based on device evaluation.The reported event could be confirmed, since the device was returned for evaluation and matches the reported failure mode.Device inspection revealed the following: the received screwdriver bit shows signs of normal and prolonged usage however its tip is found to be broken.The tip was not received for evaluation.The breakage surface shows signs of slight rotational deformation/waves.Absence of plastic deformation and presence of an uneven breakage indicates that the breakage was instantaneous due to high torsional and bending overload.However, it cannot be excluded that residual stress from previous usage may have also contributed in the breakage.The average hardness of the drill was observed to be 61.1 hrc as required against a range of 58.0 hrc ¿ 62.0 hrc.The returned screwdriver bit was found to be within specifications.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 of the failure is user related.The breakage of the tip happened due to a combination of torsional and bending overload during the surgery.If any further information is provided, the complaint report will be updated.

Event Description

It was reported there was difficulty inserting the screw due to artificial bone obstruction.The user attempted to insert the screw by power driver, but the screwdriver bit broke.

• Brand Name: SCREWDRIVER BIT AXSOS T15, AO FITTING 4.0MM LOCKING SET
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11767592
• MDR Text Key: 250942398
• Report Number: 0008031020-2021-00206
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07613327005028
• UDI-Public: 07613327005028
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

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 Model Number: 702753
• Device Catalogue Number: 702753
• Device Lot Number: J03730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Initial Date Manufacturer Received: 04/07/2021
• Initial Date FDA Received: 05/03/2021
• Supplement Dates Manufacturer Received: 06/23/2021
• Supplement Dates FDA Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1