MAUDE Adverse Event Report: STRYKER SPINE-US RADIUS M A ADJUSTMENT TOOL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	486619100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the radius height adjuster was discovered broken post surgery.The instrument was used during surgery to remove a radius rapid screw.The instrument was able to successfully remove the screw.It is unknown if the adjuster broke during the surgery.It is unknown if any fragments entered the patient cavity.There are no reports of adverse consequences to the patient.
Event or Problem Description
It was reported that the radius height adjuster was discovered broken post surgery.The instrument was used during surgery to remove a radius rapid screw.The instrument was able to successfully remove the screw.It is unknown if the adjuster broke during the surgery.It is unknown if any fragments entered the patient cavity.There are no reports of adverse consequences to the patient.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment.Result: the device was inspected and one of the prongs is fractured.It is unknown if the broken fragment was retrieved.The reported fracture was identified after the surgery and the surgery was completed successfully.No adverse reaction to the patient is reported and no surgical delay is reported.Manufacturing history was reviewed and no issues were identified.The device has been released approximately 5 years ago and have had been used over 150 times.The ifu for instrument 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.Conclusion: the possible root cause of the reported event was determined to be normal wear due to instrument age.

• Brand Name: RADIUS M A ADJUSTMENT TOOL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7538601
• Report Number: 0009617544-2018-00112
• Device Sequence Number: 13736619
• Product Code: LXH
• UDI-Device Identifier: 07613327276053
• UDI-Public: (01)07613327276053
• Combination Product (Y/N): N
• 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): 07/26/2018

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: 486619100
• Device Catalogue Number: 486619100
• Device Lot Number: 12E322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Initial Date Received by Manufacturer: 04/27/2018
• Supplement Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 05/23/2018
• Supplement Report FDA Received Date: 07/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1