MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA II ROD TEMPLATE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	03710620
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the rod template was bending, it was broken in two.Additional information indicated; the reported event occurred over the patient's cavity.
Additional Manufacturer Narrative
The reported event of rod fracture was confirmed via correspondence with the sales representative.The device was not returned and a valid lot number was not provided therefore manufacturing history could not be reviewed.Due to the device not being returned, a definite root cause cannot be determined.
Event or Problem Description
It was reported that when the rod template was bending, it was broken in two.Additional information indicated; the reported event occurred over the patient's cavity.

• Brand Name: XIA II ROD TEMPLATE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6676814
• Report Number: 0009617544-2017-00268
• Device Sequence Number: 18846325
• Product Code: LXH
• UDI-Device Identifier: 07613327262230
• UDI-Public: (01)07613327262230
• Combination Product (Y/N): N
• 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): 09/20/2017

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 Model Number: 03710620
• Device Catalogue Number: 03710620
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2017
• Supplement Date Received by Manufacturer: 06/01/2017
• Initial Report FDA Received Date: 06/29/2017
• Supplement Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1