MAUDE Adverse Event Report: STRYKER GMBH DRILL GUIDE, COMP/POLY DIA2.0MM DRILL, T8; PLATE, FIXATION, BONE

Model Number 703684

Device Problems Break (1069); Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 02/14/2022

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.

Event Description

As reported: "drill guide broke during surgery.".

• Brand Name: DRILL GUIDE, COMP/POLY DIA2.0MM DRILL, T8
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13742196
• MDR Text Key: 287712684
• Report Number: 0008031020-2022-00098
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613327069815
• UDI-Public: 07613327069815
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K132502
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 703684
• Device Catalogue Number: 703684
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2022
• 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