MAUDE Adverse Event Report: STRYKER GMBH CANNULATED TAP ASNIS III Ø4.0MM AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	702454
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.A device inspection was not possible since the affected device was not returned for evaluation and no other evidence was provided.The batch record could not be reviewed because the affected device was not returned, and the lot number was not communicated.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.Based on the risk management the probable root cause would be but not limited to; too much force applied during tapping/screwing.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device was discarded.
Event or Problem Description
As reported: "it was inserted with power tool and it was broken.Therefore, all broken parts was removed from patient body.".

• Brand Name: CANNULATED TAP ASNIS III Ø4.0MM AO FITTING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9851089
• Report Number: 0008031020-2020-00739
• Device Sequence Number: 2886361
• Product Code: LXH
• UDI-Device Identifier: 04546540112071
• UDI-Public: 04546540112071
• Combination Product (Y/N): N
• Initial Reporter Country: JP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/18/2020

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: 702454
• Device Catalogue Number: 702454
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1