MAUDE Adverse Event Report: STRYKER SPINE-US OVAL SHAVER SET 7-16MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48060907
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a paddle distractor broke within the patient's disc space.However, upon further communication it was confirmed that the instrument was actually a custom shaver that broke.The surgeon reported that no excess torque was applied to the instrument during use.No adverse consequences to the patient were reported with a surgical delay of 2 minutes.
Additional Manufacturer Narrative
Method: visual inspection, material analysis, product history review, complaint history review, labelling review, risk assessment.Result: the sales rep reported event was confirmed via visual inspection.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.All the fragments were retrieved from patient¿s cavity.There were no adverse consequence to the patient due to the reported event the device was returned in 2 pieces, with the tip of the device fractured off.A material analysis was performed.Shaver was found to have a fracture origin in the raised end and a mixed mode fracture of mostly cleavage with some ductile due to an applied torsional force.The hardness and chemical constituents were as specified on the drawing.No material or manufacturing defects were found.It is unknown how often or how many times the product has been used and unknown how long the rep have had the product for.From instruments ifu, 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.Conclusion: based on the age of the device and visual inspection, the most likely cause of the reported event was determined to be normal wear due to excessive use.
Event or Problem Description
It was reported that a paddle distractor broke within the patient's disc space.However, upon further communication it was confirmed that the instrument was actually a custom shaver that broke.The surgeon reported that no excess torque was applied to the instrument during use.No adverse consequences to the patient were reported with a surgical delay of 2 minutes.

• Brand Name: OVAL SHAVER SET 7-16MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7667801
• Report Number: 3004024955-2018-00036
• Device Sequence Number: 19174826
• Product Code: LXH
• UDI-Device Identifier: 07613327263534
• UDI-Public: (01)07613327263534
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2018

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: 48060907
• Device Catalogue Number: IS3048REL
• Device Lot Number: 21557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 10/27/2018
• Initial Report FDA Received Date: 07/06/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1