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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM/2.7MM T-PLATE/7 HOLES 85MM-VETERINARY PLATE,FIXATION,BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM/2.7MM T-PLATE/7 HOLES 85MM-VETERINARY PLATE,FIXATION,BONE Back to Search Results
Catalog Number 242.887
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

Device used in a veterinary case - no patient information will be reported. Gtin unavailable, product made prior to gtin compliance date. The 3. 5mm/2. 7mm t-plate/7 holes 85mm-veterinary (p/n: 242. 887, lot #: 4779329) was returned and received at us cq. Upon visual inspection, the device was observed to be bent. No other issues were observed with the returned device. The complaint condition was not confirmed even if the device was received bent for the 3. 5mm/2. 7mm t-plate/7 holes 85mm-veterinary (p/n: 242. 887, lot #: 4779329) as all the indications showed that the device met its mechanical properties, raw materials requirements. There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined. The potential cause could be due to unintended forces applied to the device. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities. Device history lot: part # 242. 887, synthes lot # 4779329, supplier lot # na, release to warehouse date: 04 jun 2004, manufactured by synthes (b)(4), no ncr's were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition. 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

Veterinary complaint: it was reported that on an unknown date, two (2) 3. 5mm/2. 7mm t-plates were easily bent during a testing procedure. There was no patient involvement. This report is for one (1) 3. 5mm/2. 7mm t-plate/7 holes 85mm-veterinary. This is report 1 of 2 for (b)(4).

 
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Brand Name3.5MM/2.7MM T-PLATE/7 HOLES 85MM-VETERINARY
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 Key10388632
MDR Text Key202784940
Report Number2939274-2020-03443
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 07/23/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/10/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number242.887
Device LOT Number4779329
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/13/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/04/2004
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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