MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM VAL STRUT PLATE 12 HOLES; PLATE,FIXATION,BONE

Catalog Number 02.130.260

Device Problem Device-Device Incompatibility (2919)

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

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional narrative: complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a j&j representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 on unknown date, the patient underwent for a surgery.During the surgery, end cap cross threaded into the nail and it did not fit into the tibial nail.The contralateral side, a 1.5mm strut plate was used and two of the locking holes did not engage with the screw head.The plate was implanted with cortical screws instead.It was unsure if it was due to potential over torquing of the screw.Patient consequence is unknown.No surgical delay.This complaint involves (2) devices.This report is for (1) 1.5mm val strut plate 12 holes.This report is 2 of 3 for (b)(4).

• Brand Name: 1.5MM VAL STRUT PLATE 12 HOLES
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12418260
• MDR Text Key: 272767073
• Report Number: 2939274-2021-05159
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819687967
• UDI-Public: (01)07611819687967
• Combination Product (y/n): N
• PMA/PMN Number: K141527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.130.260
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2021
• Patient Sequence Number: 1
• Treatment: TI ND CAP FR TBL NLS-EX T40 STRDR GRY/15MM EXT-STR.