MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH STRAIGHT SHELL IMPACTOR

Model Number	7004-0100
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Difficult or Delayed Separation (4044)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
Surgeon implanted a trident ii tritanium, 52mm clusterhole cup into a patient.When he proceeded to unscrew the trident ii impactor, he was unable to turn the wheel and release the impactor from the cup.He had to explant the cup and ream up to a 54 trident ii clusterhole cup and re-implant ith an original trident impactor.He could not disengage the impactor from the cup.Update: if a magnetic bolt was involved,.No surgical delay of approx 7-8 mins.
Event or Problem Description
Surgeon implanted a trident ii tritanium, 52mm clusterhole cup into a patient.When he proceeded to unscrew the trident ii impactor, he was unable to turn the wheel and release the impactor from the cup.He had to explant the cup and ream up to a 54 trident ii clusterhole cup and re-implant ith an original trident impactor.He could not disengage the impactor from the cup.Update: if a magnetic bolt was involved,.No surgical delay of approx 7-8 mins.
Additional Manufacturer Narrative
Reported event: an event regarding disassembly issue involving a trident ii impactor was reported.The event was confirmed based on evaluation of the returned devices.Method & results: -product evaluation and results: the returned devices were examined with the aid of stereo-microscope at magnifications up to 50x.The distal tip of the impactor was removed for further analysis.Hardness was performed on the impactor in accordance with astm e18.The hardness was observed to be approximately 47 hrc, meeting the drawing requirement of 40 hrc minimum.Damage consistent with the implantation process was observed on the distal tip of the impactor and the distal surface of the shell.Material transfer from the shell was observed on the distal surface of the impactor.Energy dispersive spectroscopy (eds) showed that the impactor was consistent with 17-4 ph stainless steel.Eds also showed that the shell chemistry was consistent with an astm f1472 alloy.Based on the given information no materials or manufacturing discrepancies were observed on the surfaces examined.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the evaluation of the returned devices indicated that the hardness of the impactor was observed to be approximately 47 hrc, meeting the drawing requirement of 40 hrc minimum.Damage consistent with the implantation process was observed on the distal tip of the impactor and the distal surface of the shell.Material transfer from the shell was observed on the distal surface of the impactor.Energy dispersive spectroscopy (eds) showed that the impactor was consistent with 17-4 ph stainless steel.Eds also showed that the shell chemistry was consistent with an astm f1472 alloy.Based on the given information no materials or manufacturing discrepancies were observed on the surfaces examined.The exact cause of the event could not be determined.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

• Brand Name: STRAIGHT SHELL IMPACTOR
• Common Device Name: IMPACTOR
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9520427
• Report Number: 0002249697-2019-04120
• Device Sequence Number: 14150854
• Product Code: HWA
• UDI-Device Identifier: 07613327364514
• UDI-Public: 07613327364514
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2020

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: 7004-0100
• Device Catalogue Number: 7004-0100
• Device Lot Number: ERFRH0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Initial Date Received by Manufacturer: 11/28/2019
• Supplement Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR