MAUDE Adverse Event Report: STRYKER SPINE-US REFLEX-HYBRID CALIPER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Model Number	48510100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the caliper broke while using in a surgery.All fragments were retrieved and the procedure was successfully completed with a backup instrument.There are no reports of impact to the patient.
Additional Manufacturer Narrative
Visual inspection, device history review, complaint history review, risk assessment; result: the customer reported event was confirmed via visual inspection.The caliper was confirmed to be broken through the spindle axis upon visual inspection.The lot was not visible on the instrument therefore manufacturing records for this product were not reviewed.Potential root causes include: excessive compressive force applied to the caliper.Usage of instrument beyond its expected service life.Stress concentration at the spindle hole.Previously damaged or deformed caliper (i.E.Bent tips, broken spring).
Event or Problem Description
It was reported that the caliper broke while using in a surgery.All fragments were retrieved and the procedure was successfully completed with a backup instrument.There are no reports of impact to the patient.

• Brand Name: REFLEX-HYBRID CALIPER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7247836
• Report Number: 0009617544-2018-00039
• Device Sequence Number: 16168084
• Product Code: LXH
• UDI-Device Identifier: 07613327270754
• UDI-Public: (01)07613327270754
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 05/24/2018

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 Model Number: 48510100
• Device Catalogue Number: 48510100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Initial Date Received by Manufacturer: 01/12/2018
• Supplement Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 02/07/2018
• Supplement Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1