MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 6.5MM CANNULATED SCREW 32MM THREAD 95MM; SCREW, FIXATION, BONE

Model Number 208.441

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Event date: 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 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 4 of 5 for (b)(4).

• Brand Name: 6.5MM CANNULATED SCREW 32MM THREAD 95MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7175485
• MDR Text Key: 96752220
• Report Number: 2939274-2018-50131
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886982149466
• UDI-Public: (01)10886982149466(10)LOTUNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021932
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 208.441
• Device Catalogue Number: 208.441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Weight: 120