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

Catalog Number	7030-6535
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other 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
Revision of competitor devices, left hip.While implanting a screw through a trident ii shell, the screw broke.The surgeon had used a 3.3 x 25 drill bit to prepare the acetabulum.6.5 x 35mm screw was less than halfway into the patient.Patient reportedly has sclerotic bone (hard/ dense bone quality).The portion of the screw was not sitting proud and the surgeon decided to leave that portion in the patient.Surgeon proceeded to use a 4.0 x 25 drill bit to prepare the acetabulum, and was able to implant 3 screws of smaller length (6.5 x 20 and 6.5 x 30mm).Rep confirmed there was no surgical delay.

• 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
• MDR Report Key: 8325060
• Report Number: 0002249697-2019-00899
• Device Sequence Number: 206197
• Product Code: LPH
• UDI-Device Identifier: 07613327345100
• UDI-Public: 07613327345100
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K171768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/11/2019

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: 06/30/2023
• Device Catalogue Number: 7030-6535
• Device Lot Number: 7LW
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 02/11/2019
• 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: 65 YR