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

Model Number	48280081
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when attempting to final tighten a 2 level rod and screw construct, the surgeon was unable to tighten down the blocker enough to completely stop the rods from having micro movement.
Event or Problem Description
It was reported that when attempting to final tighten a 2 level rod and screw construct, the surgeon was unable to tighten down the blocker enough to completely stop the rods from having micro movement.
Additional Manufacturer Narrative
The device was returned, and the reported event could not be confirmed.Upon visual inspection of the returned device, the tip seemed slightly deformed and rounded off.Functional and dimensional inspection were performed.The instrument was able to be tightened to the required torque without additional lubrication.As the reported event could not be confirmed, a definite root cause cannot be determined.

• 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: 7455679
• Report Number: 0009617544-2018-00089
• Device Sequence Number: 16522239
• Product Code: LXH
• UDI-Device Identifier: 07613327266313
• UDI-Public: (01)07613327266313
• 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): 09/25/2018

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: 48280081
• Device Catalogue Number: 48280081
• Device Lot Number: 13C005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Initial Date Received by Manufacturer: 03/27/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1