MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN DRILL BIT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number UNK_SEL

Device Problems Device Difficult to Setup or Prepare (1487); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2022

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

As reported: "interference with drill bit when using locking drill sleeves.The sleeve was damaged.".

Manufacturer Narrative

Please note the corrections to d9/h3 as the device was not returned for evaluation.Please also note the correction to d1.The reported event could not be confirmed for the drill bit since the device was not returned for evaluation and no other evidences were provided.A review of the device history was not possible because the lot number was not communicated.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 in relation to the drill bit.Based on the investigation that was performed for the returned drill sleeve did most likely a damage at the drill sleeve lead to the complained malfunction.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device disposition unknown.

Event Description

As reported: "interference with drill bit when using locking drill sleeves.The sleeve was damaged.".

• Brand Name: UNKNOWN DRILL BIT
• Type of Device: 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: 15666577
• MDR Text Key: 306985411
• Report Number: 0008031020-2022-00560
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1