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

Model Number	702760
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It is reported that the torque limiter is defective.
Additional Manufacturer Narrative
The reported event could be confirmed as a functional inspection was performed on the device with detailed result stated below: the device inspection revealed the following: torque limiter was tested in the lab where measurements were taken across 7 cycles in nm with results as stated - 2.451, 2.460, 2.493, 2.471, 2.491, 2.472, 2.484.It should be noted, the torque specification should be within 2.200 to 2.450 nm range; here it is clearly out of the given range.As maintenance chart for the torque limiter was unobtainable upon request, the root cause is assessed as normal wear (the part has never been inspected by the customer).Additionally noted in the 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.
Event or Problem Description
It is reported that the torque limiter is defective.

• 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: 9721512
• Report Number: 0008031020-2020-00463
• Device Sequence Number: 355186
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2020

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: 702760
• Device Catalogue Number: 702760
• Device Lot Number: V07789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1