MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNIVERSAL IMPACTOR POSTIONER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	2101-0200
Medical Device Problem Codes	Break (1069); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by rep: "trident cup introducer threads too long.Never noticed before as normally use mako introducer.Have the threads lengthened through use or is this a problem with lot? introducer handle threads protruding through window trial and definitive shell.They are too long.Surgeon had less thread inside acetabular cup and had to use final cup impactor too." case: left tha manual case.
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no similar events for the lot referenced.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Additional Manufacturer Narrative
Reported event: an event regarding damage involving a cutting edge impactor was reported.The event was confirmed via evaluation of the returned device.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that the device was returned in a used condition.The device is worn with scratches and damages on the surface.Examination of the returned device with engineer indicated that the product failure mode is consistent with that described in capa related to the threaded stud overcoming the fixation of the press fit, dowel pin and weld, and pull out of the handle shaft.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the trident cup introducer threads are too long and protruded through window trial and definitive shell during surgery.Examination of the returned device with engineer indicated that the product failure mode is consistent with that described in capa related to the threaded stud overcoming the fixation of the press fit, dowel pin and weld, and pull out of the handle shaft.Capa investigation indicated that the handle shaft and threaded stud are designed to be press fit together, and that assembly is reinforced with a cross-pinned dowel pin and weld.Under certain loading and use conditions, the threaded stud could overcome the fixation of the press fit, dowel pin, and weld, and pull out of the handle shaft.No further investigation for this event is required.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
As reported by rep: "trident cup introducer threads too long.Never noticed before as normally use mako introducer.Have the threads lengthened through use or is this a problem with lot? introducer handle threads protruding through window trial and definitive shell.They are too long.Surgeon had less thread inside acetabular cup and had to use final cup impactor too." case: left tha.Manual case.

• Brand Name: UNIVERSAL IMPACTOR POSTIONER
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18710757
• Report Number: 0002249697-2024-00236
• Device Sequence Number: 20629859
• Product Code: JDI
• UDI-Device Identifier: 07613327211511
• UDI-Public: 07613327211511
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K161569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2024

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 Catalogue Number: 2101-0200
• Device Lot Number: 132857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2015
• 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: 65 YR
• Patient Sex: Unknown