MAUDE Adverse Event Report: STRYKER GMBH DRILL SLEEVE, LOCKING Ø3.1MM, 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	06/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "when drilling, a drill bit got stuck in the middle of a drill sleeve and could neither be advanced nor removed.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the sleeve was stuck on the drill bit as complained and matches the alleged failure.The device inspection revealed the following: the inspection has shown that the drill sleeve is completely stuck on the drill bit in the received condition, no movement between the devices was possible.And there was not clearance between them.It was possible to disassemble the devices with the r&d specialist help during the investigation.After that, the drill bit showed extensive signs of degradation.Around the middle, the drill was worn out, most likely due to constant interaction with the sleeve during rotation.Minimal clearance and repeated relative surface motion may have led to fretting, most likely due to excessive misaligned rotation during the surgery, causing friction.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 a potential misalignment during use, leading to fretting.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "when drilling, a drill bit got stuck in the middle of a drill sleeve and could neither be advanced nor removed.".

• Brand Name: DRILL SLEEVE, LOCKING Ø3.1MM, SHORT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14852168
• Report Number: 0008031020-2022-00295
• Device Sequence Number: 19993413
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2022

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: K09FC66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown