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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP OLECRANON PL 2H/LT/90MM PLATE, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP OLECRANON PL 2H/LT/90MM PLATE, FIXATION, BONE Back to Search Results
Model Number 02.107.302
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Code Available (3191)
Event Date 11/29/2018
Event Type  Injury  
Manufacturer Narrative
Additional product code: hwc. Complainant part is not expected to be returned for manufacturer review/investigation. A review of the device history records has been requested. The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or 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. (b)(4). The locking screw would not lock into the plate, causing surgeon to use a cortical screw instead. 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) 2018, the variable angle (va) locking screw would not lock into one of the holes on the va locking compression plate (lcp) olecranon plate. The plate was still implanted and the surgeon implant an unknown cortical screw in that hole instead. The patient outcome was not affected but there was a 10 minute delay in the case. Procedure outcome was unknown. This report is for one (1) 2. 7mm/3. 5mm va lcp olecranon plate. This is report 1 of 2 for (b)(4).
 
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Brand Name2.7MM/3.5MM VA-LCP OLECRANON PL 2H/LT/90MM
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 14845
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8198105
MDR Text Key131469014
Report Number2939274-2018-55592
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120070
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 12/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number02.107.302
Device Catalogue Number02.107.302
Device Lot Number660782
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 Received12/02/2018
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

Patient Treatment Data
Date Received: 12/26/2018 Patient Sequence Number: 1
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