MAUDE Adverse Event Report: STRYKER SPINE-US ES2 TORQUE WRENCH; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48280081
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported an, "ease of turning," an es2 torque wrench used during the implantation of a set screw.
Event or Problem Description
A physician reported an, "ease of turning," an es2 torque wrench used during the implantation of a set screw.
Additional Manufacturer Narrative
Correction to d.10.(date): updated from 'blank' to (b)(6) 2019 visual inspection observed wear marks on returned torque wrench.The lines that indicate 12nm torque are fading indicating normal wear of instrument.Functional inspection determined the wrench was able to move "line to line" meaning it reached 12 nm.Dimensional inspection, the torque output was tested with a torque gauge and found to be within specification (12+/-1 nm).Device and complaint history records were reviewed, and no relevant manufacturing or similar complaints were identified.Per surgical technique: once the necessary correction procedures have been performed and the spine is fixed in a satisfactory position, the final tightening of the blockers is performed using the counter torque tube and the torque wrench.Place the counter torque tube down over the blades.Note: the laser markings and windows on the counter torque tube correspond to the blade lengths to indicate when the counter torque tube is fully seated.Insert the torque wrench through the counter torque tube to engage the blocker.Turn the handle of the torque wrench clockwise to align the two arrows on the torque wrench to achieve the 12nm of torque required to secure the implant construct.Repeat the process for each blocker.Note: the counter torque tube must be used for final tightening.The counter torque tube performs two important functions: 1) it allows the torque wrench to align with the tightening axis.2) it allows the optimal torque needed to lock each blocker without applying the torque to the rest of the construct.From instruments general 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.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 reported event is normal wear due to extensive use.

• Brand Name: ES2 TORQUE WRENCH
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9211665
• Report Number: 0009617544-2019-00116
• Device Sequence Number: 2903456
• Product Code: LXH
• UDI-Device Identifier: 07613327266313
• UDI-Public: 07613327266313
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/24/2020

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: 48280081
• Device Catalogue Number: 48280081
• Device Lot Number: 141474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 01/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 113