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	02/17/2022
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 axsos surgery, after using osferion for a proximal tibia fracture, the sleeve and drill got stuck when drilling with a rocking drill.Spare drill was used and the surgery was finished without any other problem.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the sleeve was stuck on the drill bit as complained.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.After disassembling, a deformation at the forefront of the drill sleeve became visible, most likely caused by a hit with another instrument or a drop to the ground.Due to this deformation the diameter at the forefront of the sleeve was reduced, which did lead to reduced clearance between the drill bit and the guide.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 bits 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 in combination with the use of damaged drill sleeve, which finally leads to fretting.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "during axsos surgery, after using osferion for a proximal tibia fracture, the sleeve and drill got stuck when drilling with a rocking drill.Spare drill was used and the surgery was finished without any other problem.".

• 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: 13789848
• Report Number: 0008031020-2022-00111
• Device Sequence Number: 4023248
• 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): 06/03/2022

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: K06E04B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2022
• Supplement Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 03/16/2022
• Supplement Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2016
• 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