MAUDE Adverse Event Report: STRYKER SPINE-US XIA TITANIUM 4.5 ROD ROTATION FORCEPS; INSTRUMENT, SURGICAL, NON-POWERED

Model Number 48130100

Device Problems Break (1069); Fracture (1260)

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

Event Date 05/31/2018

Event Type  malfunction  

Event Description

It was reported that while turning the rod, the rotation key and forceps broke.The surgery was completed successfully with alternate tools in the surgery room.No adverse consequences to the patient were reported.

Event Description

It was reported that while turning the rod, the rotation key and forceps broke.The surgery was completed successfully with alternate tools in the surgery room.No adverse consequences to the patient were reported.

Manufacturer Narrative

The initial reporter was updated from physician/surgeon to clinical support employee.

Event Description

It was reported that while turning the rod, the rotation key and forceps broke.The surgery was completed successfully with alternate tools in the surgery room.No adverse consequences to the patient were reported.

• Brand Name: XIA TITANIUM 4.5 ROD ROTATION FORCEPS
• Type of Device: INSTRUMENT, SURGICAL, NON-POWERED
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 7642887
• MDR Text Key: 113004496
• Report Number: 0009617544-2018-00156
• Device Sequence Number: 1
• Product Code: HAO
• UDI-Device Identifier: 07613327264432
• UDI-Public: (01)07613327264432
• Combination Product (y/n): N
• 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,Followup,Followup
• Report Date: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 48130100
• Device Catalogue Number: 48130100
• Device Lot Number: 132164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/14/2013
• 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