MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5 LCP MED PROXIMAL TIB PL 4H/LFT 93; PLATE, FIXATION, BONE

Model Number 239.955

Device Problem Device-Device Incompatibility (2919)

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

Event Date 05/25/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional narrative:: without a valid lot number the device history records review could not be completed.: complainant device is not expected to be returned for manufacturer review/investigation.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.Device was used for treatment, not diagnosis.

Event Description

It was reported on an unknown procedure that locking screw did not engage with one of the combo holes in the plate.A non-locking screw was used in its place.The locking screw was found not be the problem as the same screw engaged a different locking hole.Two new drill bits were also found to be dull and heated up the bone excessively when trying to drill with them.No surgical delay and patient consequence.This complaint involves 3 device.This report is for one (1) 3.5 lcp med proximal tib pl 4h/lft 93 this report is 3 of 3 for (b)(4).

• Brand Name: 3.5 LCP MED PROXIMAL TIB PL 4H/LFT 93
• 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
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA
• MDR Report Key: 12029018
• MDR Text Key: 258181454
• Report Number: 2939274-2021-03073
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982163493
• UDI-Public: (01)10886982163493
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 239.955
• Device Catalogue Number: 239.955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2021
• 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?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1