MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 6.5MM CANNULATED SCREW 32MM THREAD 80MM; SCREW, FIXATION, BONE

Model Number	208.438
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Unknown date between (b)(6) 2017.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported a revision of hip pinning was conducted on (b)(6) 2017 after the patient was implanted on (b)(6) 2017.The patient was revised to a 4.5mm proximal femur plate.Five 6.5mm partially (32mm) threaded cannulated screws (80, 90, 95, 100, 110mm) and four washers were removed from the patient; one washer was left in patient.Removal of hardware was quick and easy.The screws were replaced with a proximal femur plate as the screw fixation failed.The surgeon was unable to retrieve the washer implanted in the patient because she plated over the screw.Originally, she was going to leave it in, but then decided to try and take out the screw and the washer after plating.The screw was able to be retrieved, but not the washer.The procedure was completed successfully and the patient was reportedly stable.Concomitant devices: washer (part 219.99, lot unknown, quantity 5) this is report 5 of 5 for (b)(4).

• Brand Name: 6.5MM CANNULATED SCREW 32MM THREAD 80MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7175587
• Report Number: 2939274-2018-50132
• Device Sequence Number: 1979080
• Product Code: HWC
• UDI-Device Identifier: 10886982149435
• UDI-Public: (01)10886982149435(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K021932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 208.438
• Device Catalogue Number: 208.438
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2017
• Initial Report FDA Received Date: 01/09/2018
• 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: Required Intervention
• Patient Age: 42 YR
• Patient Weight: 120