MAUDE Adverse Event Report: STRYKER GMBH TAP SPS Ø3.5X180MM AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	702804
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the tap tip broke off and could not be removed.The procedure was terminated with the tap tip remaining in the patient's bone.In same procedure, the drill bit was broken.All debris were removed from the patient.
Additional Manufacturer Narrative
Correction to h6( device code).The reported event could be confirmed since the device was returned for evaluation and matches the alleged event.The received device shows signs of prior use, with slight nick marks observed on the cutting flutes, leading to wear of the tap flutes.A close inspection of the fracture surface indicates that the breakage occurred suddenly in a brittle manner, as there is no evidence of plastic deformation, and the surface appears shiny.The dimension analysis was conducted for the diameter of device and was observed to be within specification.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance to the values in the material specification.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.Based on the above investigation, the root cause could be determined to be user-related as breakage is caused due to application of high torsional load due with wear out flutes.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the tap tip broke off and could not be removed.The procedure was terminated with the tap tip remaining in the patient's bone.In same procedure, the drill bit was broken.All debris were removed from the patient.

• Brand Name: TAP SPS Ø3.5X180MM 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22788886
• Report Number: 0008031020-2025-01342
• Device Sequence Number: 8236501
• Product Code: LXH
• UDI-Device Identifier: 04546540372192
• UDI-Public: (01)04546540372192(10)06190L
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 702804
• Device Lot Number: 06190L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Sex: Male