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

Model Number	705004
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "during the operation, the drill sleeve could not connect to the plate.The threaded part at the tip of the sleeve was worn out.It was unknown whether it was worn out during or before surgery.Thereafter, the procedure completed without problem.".
Additional Manufacturer Narrative
D4 lot code was corrected.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 received drill sleeve reveals a severely worn out and damaged tip & outer surface.The threads at the tip of the sleeve are severely deformed.The deformed threads at the tip indicates towards application of high twisting/torsional forces during assembly with the plate, most likely during the surgery or in the previous surgery.Also, the outer surface was observed with regular deep circular scratches.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 issue is user related.The presence of excessive scratches all over the sleeve and thread deformation at the tip indicates towards a usage in an unintended manner involving high insertion force on the sleeve during the current surgery and probably in the previous surgery as well.Under intended usage such an issue would not have occurred.A prior functional check of the devices is a basic requirement before the surgery as per instructions for use (ifu).If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "during the operation, the drill sleeve could not connect to the plate.The threaded part at the tip of the sleeve was worn out.It was unknown whether it was worn out during or before surgery.Thereafter, the procedure completed without problem.".

• 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: 11593294
• Report Number: 0008031020-2021-00111
• Device Sequence Number: 17189346
• 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): 05/17/2021

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: K07419C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1