MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM UNIVERSAL TIGHTENER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48237008
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the universal tightener hex broke off.An extra tightener was available.No adverse consequences t the patient is reported.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment; result: the customer reported event was confirmed via visual inspection.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.According to the sales rep, the device is used approximately 4 times a week.Manufacturing records indicate that the instrument was manufactured in january 2013 and is approximately 5 years old.According to the instruments ifu, "for instruments designed for re-use: the life of the instrument depends on the number of times they are used as well as the precautions taken in handling, cleaning and storage.Great care must be taken of the instruments to ensure that they remain in good working order." conclusion: the plausible root cause of the reported event is most likely normal wear and tear due to the age of the instrument and its use.
Event or Problem Description
It was reported that the universal tightener hex broke off.An extra tightener was available.No adverse consequences to the patient is reported.

• Brand Name: XIA 3 TITANIUM UNIVERSAL TIGHTENER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7572703
• Report Number: 0009617544-2018-00130
• Device Sequence Number: 1988235
• Product Code: LXH
• UDI-Device Identifier: 07613327265330
• UDI-Public: 07613327265330
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2018

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: No Information
• Device Catalogue Number: 48237008
• Device Lot Number: 12D319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Initial Date Received by Manufacturer: 05/09/2018
• Supplement Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 08/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1