MAUDE Adverse Event Report: STRYKER GMBH TWIST DRILL, DIAM.2.0X102MM, WL 50MM, AO-SHAFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 45-27010S

Device Problems Bent (1059); Kinked (1339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/26/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During operation with variax-dr, drilling with twist drill after temporary fixed the plate and the dill was bent and kinked.Therefore, the tip of the drill was cut off with wire cutter and and removed from the patient body.The operation was continued with new drill.

Event Description

During operation with variax-dr, drilling with twist drill after temporary fixed the plate and the dill was bent and kinked.Therefore, the tip of the drill was cut off with wire cutter and and removed from the patient body.The operation was continued with new drill.

Manufacturer Narrative

Correction concomitant medical products and device evaluated by mfr.The reported event that "45-27010s " was alleged of "material integrity issue - deformed / distorted" could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device order and inspection record.No corrective actions are required at this time.A review of the labeling led to the above finding.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.Device was not returned.

• Brand Name: TWIST DRILL, DIAM.2.0X102MM, WL 50MM, AO-SHAFT
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7213976
• MDR Text Key: 98064658
• Report Number: 0008031020-2018-00058
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/02/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2022
• Device Catalogue Number: 45-27010S
• Device Lot Number: 6000068915
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/26/2017
• Initial Date FDA Received: 01/23/2018
• Supplement Dates Manufacturer Received: 03/06/2017
• Supplement Dates FDA Received: 04/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other