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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCREW, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCREW, FIXATION, BONE Back to Search Results
Device Problems Break; Unintended Movement
Event Type  Injury  
Manufacturer Narrative

Event date: unknown when 4. 5mm cortex screw broke and nonunion began. 510k: this report is for an unknown screws: cortex/unknown lot. Part and lot number are unknown; udi number is unknown. On (b)(6) 2018 on some parts. Complainant part is not expected to be returned for manufacturer review/investigation. Patient code (b)(4) used for: the complaint indicated that the device broke post-op requiring additional surgical intervention. 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. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 the patient underwent a revision orif (open reduction internal fixation) of a right humerus on (b)(6) 2018 due to a broken 4. 5mm cortex screw and nonunion. The patient was initially implanted with the following hardware on (b)(6) 2017; one (1) 11-hole 4. 5mm narrow locking compression plate (lcp), six (6) 4. 5mm self-tapping cortex screws, one (1) 3. 5mm self-tapping cortex screw, and two (2) 2. 7mm self-tapping cortex screws. Lengths of the screws are unknown. The 3. 5mm and 2. 7mm screws were implanted directly into the patient¿s bone to reduce the fracture and not implanted in the plate. X-rays were taken on an unknown date and revealed the broken screw and nonunion. Patient was described as ¿slow¿ with minimal support at home. The plate, five (5) 4. 5mm cortex screws, and one (1) 3. 5mm cortex screws (removed intact) were removed. The head of the broken 4. 5mm screw was floating freely in soft tissue and could not be retrieved. The body of the screw was still in solid bone and was not retrieved. The two (2) 2. 7mm cortex screws were not removed and remained part of the revised construct. No surgical delay and the procedure was completed successfully. In addition, after further review of x-rays, it has been determined that five (5) 4. 5mm self-tapping cortex screws loosened/backed out of the plate. Concomitant devices reported: 4. 5mm narrow locking compression plate (lcp) 11 holes/206mm (part # 224. 611, lot # unknown, quantity # 1), 3. 5mm self-tapping cortex screws (part # unknown, lot # unknown, quantity # 1), 2. 7mm self-tapping cortex screws (part # unknown, lot # unknown, quantity # 2). This complaint involves one (1) device. This report is 2 of 2 for (b)(4).

 
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Type of DeviceSCREW, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
michael cote
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key7445913
Report Number2939274-2018-51838
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 04/02/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/19/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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