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 Codes	Metal Shedding Debris (1804); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Primary procedure, right hip.It was reported that the screw passed entirely through the cup.The screw could not be extracted and was left in the patient but a metal shaving was retrieved from the cup.The surgeon placed another screw in the cup to provide fixation.No surgical delay was caused.
Additional Manufacturer Narrative
An event regarding an assembly issue and crack/fracture involving a bone screw was reported.The event was confirmed following a review by a clinical consultant.Conclusions: a review by a clinical consultant concluded: [.] implantation of a hex bone screw intended for supplemental screw fixation under a rather steep angle caused the relatively sharp edge of the flat screw head to cut through the relatively soft titanium of the cup shell perforating same.No adverse consequences are to be expected now or in the future.If additional information and/or device become available, this investigation will be reopened.
Event or Problem Description
Primary procedure, right hip.It was reported that the screw passed entirely through the cup.The screw could not be extracted and was left in the patient but a metal shaving was retrieved from the cup.The surgeon placed another screw in the cup to provide fixation.No surgical delay was caused.

• 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
• MDR Report Key: 7282608
• Report Number: 0002249697-2018-00488
• Device Sequence Number: 13755607
• Product Code: LPH
• UDI-Device Identifier: 07613327345001
• UDI-Public: 07613327345001
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K161569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2018

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: 04/30/2022
• Device Catalogue Number: 7030-6525
• Device Lot Number: AYUA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 04/05/2018
• 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: 61 YR