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

Model Number	2101-0200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
During trial phase of the operation, the trial itself was broken the head part of the holder was broken during nailing of acetabular shell trial.
Event or Problem Description
During trial phase of the operation, the trial itself was broken.The head part of the holder was broken during nailing of acetabular shell trial.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture 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 was performed as part of the material analysis: "the universal impactor/positioner with fracture.On visual examination, the fracture was observed through the striker plate at the end of the handle.Also the v40 trial head.The fracture surface of the striker plate remaining in the impactor/positioner, with the pellet material.The outer surface of the striker plate with impact damage observed indicating extensive use.".Material analysis: a material analysis was performed and concluded the following: "review of the universal impactor/positioner and the v40 trial head confirmed fracture to both devices.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture through the striker plate of the impactor/positioner due to brittle overload.Characterisation of the v40 trial head using stereo microscopy confirmed brittle fracture.No manufacturing or material related defects were observed on the device surfaces examined.".Clinician review: no medical records were received for review with a clinical consultant.Product history review: could not be performed as the provided lot id was invalid.Complaint history review: could not be performed as the provided lot id was invalid.Conclusions: it was reported that the impactor and trial head broke during surgery.The devices were returned for evaluation and a material analysis was performed.The material analysis concluded the following: "review of the universal impactor/positioner and the v40 trial head confirmed fracture to both devices.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture through the striker plate of the impactor/positioner due to brittle overload.Characterisation of the v40 trial head using stereo microscopy confirmed brittle fracture.No manufacturing or material related defects were observed on the device surfaces examined." no further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: UNIVERSAL IMPACTOR/POSTIONER
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12446043
• Report Number: 0002249697-2021-01533
• Device Sequence Number: 17074295
• Product Code: LPH
• UDI-Device Identifier: 07613327211511
• UDI-Public: 07613327211511
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K161569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2023

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: 2101-0200
• Device Catalogue Number: 2101-0200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 12/23/2022
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown