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

Model Number	705004
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
Event or Problem Description
The following was reported: after temporarily fixing the plate with k wire, one cortical screw was inserted to the distal hole.After that, when the surgeon drilled to insert the locking screw to the anterior proximal screw hole, the drill has stopped working inside the drill sleeve.The drill did not be removed by any means.Finally, the surgeon removed the sleeve and drill together with the plate.
Additional 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 and the whole assembly was found to be stuck with the plate.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.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, 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.
Event or Problem Description
The following was reported: after temporarily fixing the plate with k wire, one cortical screw was inserted to the distal hole.After that, when the surgeon drilled to insert the locking screw to the anterior proximal screw hole, the drill has stopped working inside the drill sleeve.The drill did not be removed by any means.Finally, the surgeon removed the sleeve and drill together with the plate.

• Brand Name: DRILL SLEEVE, LOCKING 3.1MM, SHORT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 12358168
• Report Number: 0008031020-2021-00371
• Device Sequence Number: 3936781
• Product Code: LXH
• UDI-Device Identifier: 07613327083606
• UDI-Public: 07613327083606
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1