MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5MM LOW PROFILE HEX SCREW 40MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	7030-6540
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
A screw appears broken on a post op x-ray.No delay was caused to surgery.Surgeon did not notice anything out of the ordinary while drilling or implanting.Surgeon does not feel anything special needs to be done beyond normal patient follow up.Surgeon would like a follow up report.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a screw was reported.The event was confirmed by medical review.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical information by a clinical consultant indicated: event description: a screw appears broken on a post op x-ray.No delay was caused to surgery.Surgeon did not notice anything out of the ordinary while drilling or implanting.Surgeon does not feel anything special needs to be done beyond normal patient follow up.Surgeon would like a follow up report.Implants involved: 6.5mm low profile hex screw 40mmanatomic site: left hipmaterials reviewed:05/03/2021: stryker pi reportundated/left ap hip x-ray: accoladed 2 stem, larger head and cup with broken screw in pelvis.Confirmation: the event may be confirmed.There is a broken screw passing through the cup and resting in the pelvis.Root cause: the root cause cannot be ascertained without operative notes and/or examination of the broken screw.One may want to assess the screw driver as well.Product history review: review of the device history records indicate the 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: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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
A screw appears broken on a post op x-ray.No delay was caused to surgery.Surgeon did not notice anything out of the ordinary while drilling or implanting.Surgeon does not feel anything special needs to be done beyond normal patient follow up.Surgeon would like a follow up report.

• Brand Name: 6.5MM LOW PROFILE HEX SCREW 40MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11876650
• Report Number: 0002249697-2021-00920
• Device Sequence Number: 1060004
• Product Code: LPH
• UDI-Device Identifier: 07613327345117
• UDI-Public: 07613327345117
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K171768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2021

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 Expiration Date: 11/30/2025
• Device Model Number: 7030-6540
• Device Catalogue Number: 7030-6540
• Device Lot Number: ZZA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 06/18/2021
• 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: 63 YR