MAUDE Adverse Event Report: STRYKER GMBH DRILL SLEEVE, LOCKING 3.1MM, SHORT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 705004

Device Problems Device Damaged by Another Device (2915); Mechanical Jam (2983)

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

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

As reported: " the drill bit was crimped to the drill sleeve during use and could not be removed.The drill bit was new.".

Manufacturer Narrative

The reported event could be confirmed, since the device was returned for evaluation and matches the reported failure mode.The device inspection revealed the following: the drill sleeve showed normal signs of usage, overall.However, after disassembling, it was observed that the edges of the sleeve at the exit point of the cannulation were all roughed up and worn out.This is a direct result of the drill making contact with the sleeve under intense usage, up to a point leading to deformation.After disassembling, a functional inspection was performed.The drill was not able to pass through the sleeve.A resistance could be felt during insertion, due to the constriction in the sleeve¿s cannulation at the exit.A dimensional inspection was performed on the sleeve.The inner diameter (at the exit point of the cannulation) was found to be undersized from one axis, which was the reason for constriction.The observed diameter was 3.13mm against a required range of 3.15mm to 3.20mm.This was caused due to the interaction of the drill with the sleeve.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 manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation, the root cause of the jamming is user related.The drill under intense usage, interacted with the sleeve, causing severe deformation to both the drill and the sleeve, leading to jamming.If any further information is provided, the complaint report will be updated.

Event Description

As reported: " the drill bit was crimped to the drill sleeve during use and could not be removed.The drill bit was new.".

• Brand Name: DRILL SLEEVE, LOCKING 3.1MM, SHORT
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11121225
• MDR Text Key: 227973287
• Report Number: 0008031020-2021-00005
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07613327083606
• UDI-Public: 07613327083606
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

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: 705004
• Device Catalogue Number: 705004
• Device Lot Number: K061E08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 01/05/2021
• Supplement Dates Manufacturer Received: 01/27/2021
• Supplement Dates FDA Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1