MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN DRILL BIT INSTRUMENT

Catalog Number UNK_SEL

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/01/2020

Event Type  Malfunction  

Manufacturer Narrative

Device was not returned. If additional information becomes available, it will be provided in a supplemental report. Partially left in patient; other part unknown.

Event Description

The customer reported that the patient was having an operation for fixation of a distal tibial fracture with plate and screws. Drilling one of the screw holes through the plate for a locking screw, the drill tip was broken inside the bone. All the metal part is present in the bone.

• Brand Name: UNKNOWN DRILL BIT
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: kevin smith ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9772223
• MDR Text Key: 193409751
• Report Number: 0008031020-2020-00525
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (Y/N): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: HEALTH PROFESSIONAL

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/28/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 02/28/2020
• 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?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/05/2020
• 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