MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM CORONAL ROD BENDER RIGHT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48230190
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon putting a coronal bend in the rod, the coronal bender broke.Surgery was successfully completed with a coronal bender in a backup set.There are no reports of adverse health consequences.
Additional Manufacturer Narrative
The customer reported event was confirmed via correspondence.The device was not returned thus visual inspection could not be performed.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The device was found to be manufactured in 2010, making it almost 8 years old at the time of the event.Most likely root cause is wear due to the device's extended use.The instruments ifu states that "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.".
Event or Problem Description
It was reported that upon putting a coronal bend in the rod, the coronal bender broke.Surgery was successfully completed with a coronal bender in a backup set.There are no reports of adverse health consequences.

• Brand Name: XIA 3 TITANIUM CORONAL ROD BENDER RIGHT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7239709
• Report Number: 0009617544-2018-00028
• Device Sequence Number: 19046042
• Product Code: LXH
• UDI-Device Identifier: 07613327265040
• UDI-Public: (01)07613327265040
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2018

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: Health Professional
• Device Model Number: 48230190
• Device Catalogue Number: 48230190
• Device Lot Number: 101337
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/06/2018
• Supplement Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 02/03/2018
• Supplement Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1