MAUDE Adverse Event Report: STRYKER GMBH LOCKING DRILL SLEEVE, LONG IMN INSTRUMENTS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	23514280
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "it was confirmed that the 23514280 was worn and the fit with 23510070 was loose.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received drill sleeve shows signs of usage all over its body.The tip of the drill sleeve was found slightly deformed along with the marking on the body was also faded.The locking area at the plastic knob is chipped off and deformed on both sides.A pre-surgical functional test was conducted with the returned drill sleeve with a sample sleeve and due to damage, it cannot be locked with the drill sleeve.Hence confirming the alleged issue.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation, the root cause was attributed to both user-related & normal wear-related issues.The failure was most likely caused by the mishandling of the device during repetitive usage.Also, the fact that repetitive sterilization and reprocessing cycles may have also contributed to the weakening of the material structural integrity cannot be neglected if any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "it was confirmed that the 23514280 was worn and the fit with 23510070 was loose.".

• Brand Name: LOCKING DRILL SLEEVE, LONG IMN INSTRUMENTS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17550453
• Report Number: 0009610622-2023-00281
• Device Sequence Number: 17813512
• Product Code: LXH
• UDI-Device Identifier: 07613327368178
• UDI-Public: 07613327368178
• 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): 10/09/2023

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 Catalogue Number: 23514280
• Device Lot Number: KP431173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2020
• 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