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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5 LCP SUP ANT CLAVICLE PLATE 8H/LT/120 PLATE, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5 LCP SUP ANT CLAVICLE PLATE 8H/LT/120 PLATE, FIXATION, BONE Back to Search Results
Model Number 02.112.031
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/08/2021
Event Type  malfunction  
Manufacturer Narrative
Product complaint #(b)(4). Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation. Investigation summary: product was not returned. Based on the information available, it has been determined that no corrective and preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable 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 that on (b)(6) 2021, the locking compression plate (lcp) anterior clavicle plate does not fit properly. The surgeon had to perform multiple bends in order to make the plate fit. There was a ten (10) minutes surgical delay. The procedure was successfully completed. There was no patient consequence reported. Concomitant device reported: unknown plate bender (part# unknown, lot# unknown, quantity 1). This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
 
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Brand Name3.5 LCP SUP ANT CLAVICLE PLATE 8H/LT/120
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
ELMIRA
35 airport road
horseheads NY
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 
MDR Report Key12096034
MDR Text Key259658690
Report Number2939274-2021-03337
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
PMA/PMN Number
K111540
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 06/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number02.112.031
Device Catalogue Number02.112.031
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 Received06/08/2021
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? Yes
Type of Device Usage Unkown

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