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.
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
D9 / h3 updated to indicate device was not returned.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.A device inspection was not possible since the affected device was not returned, and no other evidences were provided for investigation.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.More information as well as the affected device must be available in order to determine the exact root cause.If the device is returned or if any further information is provided, the complaint report will be updated.H3 other text : device disposition is unknown.

• 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: 12280415
• Report Number: 0008031020-2021-00340
• Device Sequence Number: 19753162
• 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): 10/25/2021

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?: No
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 10/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1