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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 Problem Unintended Movement
Event Type  Injury  
Manufacturer Narrative

Date of event is unknown. This report is for three (3) unknown screws/unknown lot. Part and lot number are unknown; udi number is unknown. Implant date is unknown. Explant date is unknown. Complainant part is not expected to be returned for manufacturer. Therapy date of concomitant device is unknown. Without a lot number the device history records review could not be completed. The manufacture date is unknown. The investigation could not be completed; no conclusion could be drawn, as no product was received. (b)(4). 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 that during an unknown surgical procedure, the shaft screws of a 3 hole proximal humerus plate pulled out of the bone and reduction was lost. More specifically, screws were locked to the plate and the plate moved with the screws. The three hole plate was replaced with an eight hole proximal humerus plate product number 341. 921 along with a 10 hole 2. 7 mm lcp plate. It was unknown if there was a surgical delay. Patient outcome was not reported. Concomitant part: part number 241. 901, lot number unknown. This report is for three (3) unknown screws. This is report 1 of 1 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 Key7645029
Report Number2939274-2018-52672
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 06/04/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/28/2018
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 Received06/19/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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