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

Model Number 705004

Device Problems Separation Failure (2547); Mechanical Jam (2983)

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

Event Date 07/07/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported: "the drill and sleeve stuck during drilling".

Event Description

As reported: "the drill and sleeve stuck during drilling.".

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 and the drill sleeve were found to be stuck with each other.After dis-assembling, the drill sleeve showed normal signs of usage.Proximal opening of the sleeve appears degraded, most likely due to interaction with the drill.Minimal clearance and misalignment of the drill may have led to such a situation.A combination of friction and metal debris generated potentially clogged the assembly.A review of the device history for the reported lot did not indicate any abnormalities.A review of the labeling did not indicate any abnormalities.Based on the investigation, with the extent of damage, it can be ascertained that the root cause of the issue is user related.Drill getting stuck inside the sleeve is a direct result of excessive friction between the drill and the sleeve due to misalignment during use.If any further information is provided, the complaint report will be updated.

• 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: 12246318
• MDR Text Key: 264092783
• Report Number: 0008031020-2021-00321
• 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: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• 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: K0A0748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Date Manufacturer Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1