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

Catalog Number	702602
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.H3 other text : device remains implanted.
Event or Problem Description
As reported: "attention turned to the olecranon.Dorsal incision over elbow made and carried to the dorsal ulna.The fracture was exposed and cleared of debris.The olecranon process was reduced to the proximal ulna.A 2.0mm mini fragment plate was placed dorsolaterally to maintain the reduction.We proceeded to definitive fixation with the plan to use a large 6.5mm cannulated screw intramedullary.A 2cm split was made in the distal triceps.A guidewire was placed and inserted in antegrade fashion down the ulnar canal.It was then over drilled.A 6.5mm tap was inserted, but upon insertion the tap malfunctioned and broke.There was no safe way to retrieve the broken tap without significant damage to the ulna.I elected to abandon intramedullary fixation and perform plate fixation definitively to the olecranon.A 2.7mm mini fragment plate was selected and bent to contour the proximal ulna.It was applied dorsally.A combination of both locking and non-locking screws were placed proximally and distally to the fracture.The broken tap was left in place since it was well fixed and contained within bone.Final fluoroscopic images obtained.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned and no additional information was available.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as 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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "attention turned to the olecranon.Dorsal incision over elbow made and carried to the dorsal ulna.The fracture was exposed and cleared of debris.The olecranon process was reduced to the proximal ulna.A 2.0mm mini fragment plate was placed dorsolaterally to maintain the reduction.We proceeded to definitive fixation with the plan to use a large 6.5mm cannulated screw intramedullary.A 2cm split was made in the distal triceps.A guidewire was placed and inserted in antegrade fashion down the ulnar canal.It was then over drilled.A 6.5mm tap was inserted, but upon insertion the tap malfunctioned and broke.There was no safe way to retrieve the broken tap without significant damage to the ulna.I elected to abandon intramedullary fixation and perform plate fixation definitively to the olecranon.A 2.7mm mini fragment plate was selected and bent to contour the proximal ulna.It was applied dorsally.A combination of both locking and non-locking screws were placed proximally and distally to the fracture.The broken tap was left in place since it was well fixed and contained within bone.Final fluoroscopic images obtained.".

• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18578738
• Report Number: 0008031020-2024-00014
• Device Sequence Number: 18087664
• Product Code: LXH
• UDI-Device Identifier: 04546540112774
• UDI-Public: 04546540112774
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 03/04/2024

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: 702602
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 03/04/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown