MAUDE Adverse Event Report: STRYKER SPINE-US REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRACTOR; ORTHOPAEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48511906B
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a scheduled revision of a cervical plate, the tip of the inner shaft of a reflex hybrid driver broke off.The fractured piece was removed from the surgical site.There were no adverse consequences to the patient.The procedure was completed successfully with a 1 minute surgical delay by using an alternatively available instrument.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.  device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.For instruments designed for re-use: 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.Instruments should be examined for wear or damage by doctors and staff in operating centers prior to surgery.The examination shall include a visual and functional inspection of the working surfaces, articulation points, and springs.It should also include verifying all welded connections, that all components are present, and the cleanliness of the orifices and cavities, as well as the absence of any cracks, distortion, impact, corrosion or other change.For instruments with articulations, lubrication may be necessary.Using a silicone lubricating cream is recommended.Most likely cause of the reported event is normal wear due to age of the device.H3 other text : status and location of the device is unknown.
Event or Problem Description
It was reported that during a scheduled revision of a cervical plate, the tip of the inner shaft of a reflex hybrid driver broke off.The fractured piece was removed from the surgical site.There were no adverse consequences to the patient.The procedure was completed successfully with a 1 minute surgical delay by using an alternatively available instrument.

• Brand Name: REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRACTOR
• Common Device Name: ORTHOPAEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11686261
• Report Number: 0009617544-2021-00063
• Device Sequence Number: 16924546
• Product Code: LXH
• UDI-Device Identifier: 07613327276855
• UDI-Public: 07613327276855
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2021

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: 48511906B
• Device Catalogue Number: 48511906B
• Device Lot Number: 14G971
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1