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	07/16/2021
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
It was reported that when using a sterilized drill through a sleeve, the sleeve and drill got stuck.The surgeon opened the spare drill tip and used it with another sleeve, but the same event occurred in other hole.After that, the surgery was completed using a 3mm k wire as a substitute and a tap.
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 sleeve showed normal signs of usage, overall but the external surface of the sleeve was severely damaged most likely caused in an attempt to extract the stuck drill inside.The drill sleeve was cut to further investigate and the cut section revealed that the drill is welded inside the sleeve, most likely due to excessive misaligned rotation during the surgery, causing friction.Slightly abraded inner surface of the sleeve, due to frequent usage, was also observed which may have been another reason for excessive friction.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.Drill getting stuck (welded) inside the sleeve is a direct result of excessive friction between the drill and the sleeve due to a potential misalignment during use causing excessive friction to an extent of devices getting welded.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that when using a sterilized drill through a sleeve, the sleeve and drill got stuck.The surgeon opened the spare drill tip and used it with another sleeve, but the same event occurred in other hole.After that, the surgery was completed using a 3mm k wire as a substitute and a tap.

• 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: 12280418
• Report Number: 0008031020-2021-00338
• Device Sequence Number: 3681308
• 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): 10/20/2021

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: K048138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1