MAUDE Adverse Event Report: STRYKER SPINE-US XIA II TORQUE WRENCH; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03807028
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the surgeon went to lock the nut, the tip of the xia ii titanium torque wrench fractured.This event resulted in a 15 minute surgical delay to remove the broken part.The device has been in use approximately "7 years and used an estimated 700 times." no adverse consequences to the patient.
Additional Manufacturer Narrative
Visual inspection confirmed that the tip of the torque wrench fractured off.The fractured piece was returned as well.Device history records were reviewed and no relevant manufacturing issues were identified.Complaint history records were reviewed and multiple similar complaints were identified.This device complaint has been addressed and is covered under a previous capa.Material analysis was performed as part of capa investigation.The root cause is incorrect heat treatment of the torsion shaft material which resulted in embrittlement.This lot was included as part of a recall for this issue and the recall notification was completed and executed.
Event or Problem Description
It was reported that when the surgeon went to lock the nut, the tip of the xia ii titanium torque wrench fractured.This event resulted in a 15 minute surgical delay to remove the broken part.The device has been in use approximately "7 years and used an estimated 700 times." no adverse consequences to the patient.

• Brand Name: XIA II TORQUE WRENCH
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8826448
• Report Number: 0009617544-2019-00090
• Device Sequence Number: 2625116
• Product Code: LXH
• UDI-Device Identifier: 07613327262292
• UDI-Public: 07613327262292
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2019

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: 03807028
• Device Lot Number: 127179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2019
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1