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	05/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
Event or Problem Description
As reported: "during surgery, the drill stuck to the drill sleeve.Once the surgeon took it out of the patient with the sleeve, the drill was biting into the sleeve.After that, other instruments were used and the surgery was finished without problem.".
Event or Problem Description
As reported: "during surgery, the drill stuck to the drill sleeve.Once the surgeon took it out of the patient with the sleeve, the drill was biting into the sleeve.After that, other instruments were used and the surgery was finished without problem.".
Additional Manufacturer Narrative
D9 / h3 updated to indicate device was returned.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.Drill¿s cutting edges are also deformed and dented at multiple location which most likely have been caused when it was held with a clamping device to extract it.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 torsional forces and misalignment causing friction during the surgery the batch record could not be reviewed because the lot number was not communicated and could not be identified from the returned product.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
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 12071675
• Report Number: 0008031020-2021-00274
• Device Sequence Number: 17105871
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2021

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Initial Date Received by Manufacturer: 05/31/2021
• Supplement Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 06/25/2021
• Supplement Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1