MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5MM LOW PROFILE HEX SCREW 20MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	7030-6520
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The screw tip was broken off inside the body during screw insertion and remained inside the body.
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 other similar events for the lot referenced.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.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a hip screw was reported.The event was not confirmed.Method & results: product 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 concerns a patient who underwent a cementless total hip arthroplasty and during the surgery it was noted that the tip of one of the screws used to transfix the acetabular component had broken off.It was decided to leave it insight you.No other information was given.I cannot definitely confirm this event since i was not able to see a broken screw tip on the x-rays provided.I can confirm that the patient did indeed undergo a total hip arthroplasty using screws as adjunct fixation for the acetabulum since i was able to see postoperative x-rays.The root cause of this event cannot be determined with absolute certainty.The causes of screw tip breakage are multifactorial including, most likely, surgical technique in that the path the screw took within the whole of the acetabular component may have been aberrant.Implant factors could contribute but this would only be after it was submitted to stryker engineers for metallurgical analysis and evaluation to see if there were any material defects.I would not implicate patient factors in this event." 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 during a hip replacement, the screw tip was broken off inside the body during screw insertion and remained inside the body.A review of the provided medical records by a clinical consultant indicated: "this case concerns a patient who underwent a cementless total hip arthroplasty and during the surgery it was noted that the tip of one of the screws used to transfix the acetabular component had broken off.It was decided to leave it insight you.No other information was given.I cannot definitely confirm this event since i was not able to see a broken screw tip on the x-rays provided.I can confirm that the patient did indeed undergo a total hip arthroplasty using screws as adjunct fixation for the acetabulum since i was able to see postoperative x-rays.The root cause of this event cannot be determined with absolute certainty.The causes of screw tip breakage are multifactorial including, most likely, surgical technique in that the path the screw took within the whole of the acetabular component may have been aberrant.Implant factors could contribute but this would only be after it was submitted to stryker engineers for metallurgical analysis and evaluation to see if there were any material defects.I would not implicate patient factors in this event." the exact cause of the event could not be determined because insufficient information was provided.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The screw tip was broken off inside the body during screw insertion and remained inside the body.

• Brand Name: 6.5MM LOW PROFILE HEX SCREW 20MM
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 17633911
• Report Number: 0002249697-2023-00961
• Device Sequence Number: 15376464
• Product Code: LPH
• UDI-Device Identifier: 07613327345094
• UDI-Public: 07613327345094
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171768
• 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): 12/11/2023

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 Catalogue Number: 7030-6520
• Device Lot Number: XLDE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2023
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2022
• 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 Age: 68 YR
• Patient Sex: Male
• Patient Weight: 88 KG