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

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).

• Brand Name: 3.5MM/2.7MM T-PLATE/7 HOLES 85MM-VETERINARY
• Type of Device: PLATE,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 Key: 10388632
• MDR Text Key: 202784940
• Report Number: 2939274-2020-03443
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 242.887
• Device Lot Number: 4779329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2004
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1