MAUDE Adverse Event Report: STRYKER GMBH CANNULATED TAP ASNIS III Ø6.5MM FOR SCREWS Ø6.5MM LARGE AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	702602
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that "during an operation for a fracture of the neck of the right femur, the surgeon did not feel the tap break during his operation.He noticed it during the scan.As an immediate solution, he tried to remove it, without success.He therefore left it in place and changed his aim to place two other neck screws.The fragment of the tap that remained in place can be seen on the radiograph." the procedure was delayed by 60 min.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Correction - please refer to d4 lot number and d9/h3-the product was not returned.The received x-ray was reviewed and the reported event could be confirmed as there are on the x-ray two fragments of the broken cannulated tap visible.A device inspection was not possible since the affected device was not returned, therefore no further evaluation is possible.A review of the device history was not possible because the provided lot number was invalid.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.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device disposition is unknown.
Event or Problem Description
The customer reported that "during an operation for a fracture of the neck of the right femur, the surgeon did not feel the tap break during his operation.He noticed it during the scan.As an immediate solution, he tried to remove it, without success.He therefore left it in place and changed his aim to place two other neck screws.The fragment of the tap that remained in place can be seen on the radiograph." the procedure was delayed by 60 min.

• Brand Name: CANNULATED TAP ASNIS III Ø6.5MM FOR SCREWS Ø6.5MM LARGE AO FITTING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15223429
• Report Number: 0008031020-2022-00391
• Device Sequence Number: 17718320
• Product Code: LXH
• UDI-Device Identifier: 04546540112774
• UDI-Public: 04546540112774
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2022

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: 702602
• Device Catalogue Number: 702602
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown