MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5MM LOW PROFILE HEX SCREW 25MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	7030-6525
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2023
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 similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.H3 other text : not returned to the manufacturer.
Event or Problem Description
While performing a primary total hip replacement, the surgeon decided to placed screws into the acetabular component.A 25mm 3.3 drill bit was used, with the appropriate drill guide, to prepare the screw hole.After using the depth gauge, the surgeon decided to implant a 25mm screw, using the 6.5 hex driver on the ratcheting handle.The majority of the screw was implanted into the acetabulum, when the ahead of the screw broke off of the screw body.The remaining shank of the screw was sitting proud to the inner portion of the acetabular shell.The surgeon decided to leave the broken portion of the screw that was embedded in the acetabulum.The patient received an intra-operative x-ray and the surgical time was extended as a direct result of this event.Update per response: "while performing a primary total hip replacement, the surgeon decided to placed screws into the acetabular component.A 25mm 3.3 drill bit was used, with the appropriate drill guide, to prepare the screw hole.After using the depth gauge, the surgeon decided to implant a 25mm screw, using the 6.5 hex driver on the ratcheting handle.The majority of the screw was implanted into the acetabulum, when the head of the screw broke off of the screw body.The remaining the screw was sitting proud to the inner portion of the acetabular shell.The surgeon decided to leave the broken portion of the screw that was embedded in the acetabulum.A high speed burr was used to shave the proud portion of the screw until flush with the shell.A trial mdm metal liner was used to assess if any portion of the broken screw would affect proper engagement of the liner and acetabular shell.The liner implant was impacted and a four-quadrant test performed to ensure proper engagement of the locking mechanism.An intra-operative x-ray was taken to look for any pieces of the screw left in the wound unintentionally.The hip arthroplasty continued as planned.".

• Brand Name: 6.5MM LOW PROFILE HEX SCREW 25MM
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18009588
• Report Number: 0002249697-2023-01264
• Device Sequence Number: 7537977
• Product Code: LPH
• UDI-Device Identifier: 07613327345001
• UDI-Public: 07613327345001
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K171768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/26/2023

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: 7030-6525
• Device Lot Number: UETA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2023
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 141 KG