MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5MM LOW PROFILE HEX SCREW 35MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	7030-6535
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2022
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.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.
Event or Problem Description
Primary procedure, left hip.It was reported that post-op x-ray showed that the screw was bent/ curved.Screw was not bent or curved when taken out of the packaging.Surgeon used 25mm drill with guide to drill the pilot hole.Patient's bone quality unknown but was reported as 'not young, strong bone'.Surgeon does not have any plan to revise the patient.Update per sales rep: 35mm screw is bent.
Additional Manufacturer Narrative
Reported event: an event regarding damage involving an other hip screw was reported.The event was not confirmed.Method & results: device evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.Clinician review: a review of the provided medical records by a clinical consultant indicated: this case reports the possibility of a screw bending upon insertion through an acetabular component.In my opinion i don't believe a well-directed screw would bend upon simple unobstructed insertion no matter what the quality of the bone.In order for it to bend it would either have to strike a very hard surface and be forced in or the screw was misdirected and possibly levered against the acetabular screw hole upon insertion.Having said that i would need to have further x-rays to confirm that the screw was indeed bent since the x-ray provided in my opinion is slightly distorted.I cannot absolutely confirm that this event occurred despite the x-ray showing what appears to be a bent screw.I would like to see further evidence with other x-rays.The root cause of a bent screw would have to be either contact with a very hard surface as it was forced in and inserted or misdirection with levering of the screw on the acetabular screw hole as it enters the bone.Most likely the cause is iatrogenic.Device history review: review of the product history records indicate devices were manufactured and accepted into final stock with no reported relevant discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: a review of the provided medical records by a clinical consultant indicated: a review of the provided medical records by a clinical consultant indicated: this case reports the possibility of a screw bending upon insertion through an acetabular component.In my opinion i don't believe a well-directed screw would bend upon simple unobstructed insertion no matter what the quality of the bone.In order for it to bend it would either have to strike a very hard surface and be forced in or the screw was misdirected and possibly levered against the acetabular screw hole upon insertion.Having said that i would need to have further x-rays to confirm that the screw was indeed bent since the x-ray provided in my opinion is slightly distorted.I cannot absolutely confirm that this event occurred despite the x-ray showing what appears to be a bent screw.I would like to see further evidence with other x-rays.The root cause of a bent screw would have to be either contact with a very hard surface as it was forced in and inserted or misdirection with levering of the screw on the acetabular screw hole as it enters the bone.Most likely the cause is iatrogenic.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Primary procedure, left hip.It was reported that post-op x-ray showed that the screw was bent/ curved.Screw was not bent or curved when taken out of the packaging.Surgeon used 25mm drill with guide to drill the pilot hole.Patient's bone quality unknown but was reported as 'not young, strong bone'.Surgeon does not have any plan to revise the patient.Update per sales rep: 35mm screw is bent.

• Brand Name: 6.5MM LOW PROFILE HEX SCREW 35MM
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14961293
• Report Number: 0002249697-2022-00989
• Device Sequence Number: 12133976
• Product Code: LPH
• UDI-Device Identifier: 07613327345100
• UDI-Public: 07613327345100
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2022

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: 7030-6535
• Device Catalogue Number: 7030-6535
• Device Lot Number: XJDH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 10/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2022
• 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