MAUDE Adverse Event Report: STRYKER GMBH TORQUE LIMITER 2.5NM, AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	702760
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that the torque limiter does not work properly.Did not hear a click sound during torque, and tried it several times, but it did not work properly.No surgical delay or adverse consequences were reported.
Event or Problem Description
It was reported that the torque limiter does not work properly.Did not hear a click sound during torque, and tried it several times, but it did not work properly.No surgical delay or adverse consequences were reported.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the visual inspection reveals physical damage due to wear on ao coupling of torque limiter.The functional inspection of the torque limiter was conducted in the lab where measurements were taken across 10 cycles in nm with results as stated: 4.807, 4.735, 4.746, 4.988, 4.790, 4.739, 4.640, 4.435, 4.529 and 4.572 nm.Note: torque specification should be within 2.25 to 2.75nm range; here it is clearly out of the given range.The root cause is assessed as normal wear.Note: v15097 rev aa (instruments ifu) ¿ ¿before every operation, ensure that all devices to be used during the operation function correctly with each other." a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the complaint report will be updated.

• Brand Name: TORQUE LIMITER 2.5NM, AO FITTING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8716501
• Report Number: 0008031020-2019-00685
• Device Sequence Number: 11268089
• Product Code: LXH
• UDI-Device Identifier: 04546540693532
• UDI-Public: 04546540693532
• Combination Product (Y/N): N
• 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): 08/09/2019

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 Catalogue Number: 702760
• Device Lot Number: F02257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 08/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1