MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP T-PLATE 3H HEAD/ 5H SHAFT/74MM-OBLIQUE RIGHT; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number 241.051

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.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.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, during an open reduction internal fixation (orif) of a proximal radius, the surgeon had to cut the locking compression plate (lcp) t- plate to fit the proximal radius.There was no surgical delay.The procedure was successfully completed.There was no patient consequence reported.This report is for (1) 3.5mm lcp t-plate 3h head/ 5h shaft/74mm-oblique right.This is report 1 of 1 for (b)(4).

• Brand Name: 3.5MM LCP T-PLATE 3H HEAD/ 5H SHAFT/74MM-OBLIQUE RIGHT
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13119089
• MDR Text Key: 285014316
• Report Number: 2939274-2021-07282
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 10886982165596
• UDI-Public: 10886982165596
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 241.051
• Device Catalogue Number: 241.051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - CUTTING INSTRUMENTS: TRAUMA
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 84 KG