MAUDE Adverse Event Report: STRYKER GMBH FIXED ANGLE GUIDE OMEGA 135°; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	704013
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
Event or Problem Description
The customer reported that when the surgeon was completing a dhs with cannulated screws, he tried to feed a 3.2mm wire into a 2.8mm wire hole.The washer on the angle guide has subsequently broken off and gone into the patient.The customer further reported that one of the metallic tubes which got pushed out of the guide into the patient.They were unable to retrieve the tube and after discussions with the consultant surgeon in charge the decision was made to leave it in situ as removing it would cause more trauma.The patient did undergo a longer operation time due to the incident.Attempts were made to remove the device.The surgical delay was 15 minutes.

• Brand Name: FIXED ANGLE GUIDE OMEGA 135°
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9345753
• Report Number: 0008031020-2019-01868
• Device Sequence Number: 2167179
• Product Code: LXH
• UDI-Device Identifier: 04546540451194
• UDI-Public: 04546540451194
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2019

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: 704013
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 11/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1