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	07/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "axsos-dt (anterior lateral) is being used for tibial pilon fracture.During the first distal locking drill, the drill and sleeve got stuck.It was turned it to push the drill forward, but it stuck and did not proceed.Attempted to remove the drill once, but it did not rotate in the forward rotation, so when tried to remove it by rotating in the reverse direction, the sleeve also rotated in the reverse direction and came off the plate.Grabbed the sleeve with pliers and slowly rotated the drill to try to pull it out, but it didn't come off at all.He decided that he couldn't use it, so he opened another new one and continued the operation with another sleeve.Still the same thing happened.However, this time, pulled it out immediately, grasped the sleeve with pliers, and slowly turned the drill to pull it out.In the surgical field, the sleeve was drilled several times to confirm, and the operation was continued.".
Event or Problem Description
As reported: "axsos-dt (anterior lateral) is being used for tibial pilon fracture.During the first first distal locking drill, the drill and sleeve got stuck.It was turned it to push the drill forward, but it stuck and did not proceed.Attempted to remove the drill once, but it did not rotate in the forward rotation, so when tried to remove it by rotating in the reverse direction, the sleeve also rotated in the reverse direction and came off the plate.Grabbed the sleeve with pliers and slowly rotated the drill to try to pull it out, but it didn't come off at all.He decided that he couldn't use it, so he opened another new one and continued the operation with another sleeve.Still the same thing happened.However, this time, pulled it out immediately, grasped the sleeve with pliers, and slowly turned the drill to pull it out.In the surgical field, the sleeve was drilled several times to confirm, and the operation was continued.".
Additional Manufacturer Narrative
Correction: please refer to h6 component code.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 and the drill sleeve were found to be stuck with each other.After disassembling, the drill sleeve showed normal signs of usage.Proximal opening of the sleeve appears degraded, most likely due to interaction with the drill.Minimal clearance and repeated relative surface motion may have led to fretting.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.

• 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12369746
• Report Number: 0008031020-2021-00380
• Device Sequence Number: 17134901
• 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): 11/11/2021

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: 09/03/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2016
• 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