MAUDE Adverse Event Report: STRYKER GMBH DRILL SLEEVE, LOCKING Ø3.1MM, SHORT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	705004
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "interference with drill bit when using locking drill sleeves.The sleeve was damaged.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Please note the corrections to d2a, d2b and h6 method codes.The reported event could be confirmed, since the device is in the received condition not functional as required anymore.The device inspection revealed the following: the visual inspection has shown that at the forefront of the sleeve there is a deformation visible on one side and due to this deformation the bore is not round anymore in this area, which reduces the diameter of the bore.Due to this deformation of the bore a proper insertion of a drill bit is not possible anymore.In general the device is in a very used condition.There are stress marks, nicks and scratches all over.There are also deep marks from a forceps at the head of the device visible, which indicates that the sleeve was once exposed to very high forces.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by applying excessive lateral forces onto the drill sleeve which did lead to a deformation at the forefront of the device.Wear and tear may also have played a certain role as the device did obviously reach the end of its useful life.In this relation following statement from appendix 2 of the cleaning and sterilization guide can be pointed out: ''functional check for drill guides description and function: soft tissue protection sleeves used during drilling product group: complex / multi-component medical devices with challenging features potential failure modes: scratched outer surfaces, dents at the sleeve tips preventive maintenance: use an appropriate instrument spray for the mechanism of all moving parts and articulating surfaces.In case of failure, the instrument must be replaced and not be used.'' if more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "interference with drill bit when using locking drill sleeves.The sleeve was damaged.".

• 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: 15666321
• Report Number: 0008031020-2022-00559
• Device Sequence Number: 17927488
• 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): 12/12/2022
• 2 Devices were Involved in the Event: 1 2

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: K0741A0
• 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: 09/27/2022
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2016
• 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