MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 60; PLATE,FIXATION,BONE

Model Number 02.211.060

Device Problem Device-Device Incompatibility (2919)

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

Event Date 08/05/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional narrative: additional product code: hwc.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 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 that (b)(6) 2021, the patient underwent for a surgery.During the surgery, the va locking screw would not lock into plate hole.The procedure was completed successfully without surgical delay.Patient outcome was unknown.Concomitant device reported: unknown screwdriver (part# unknown; lot# unknown; quantity: 1).This complaint involves two(2) devices.This report is for (1) 2.7 va lckng scr slf-tpng t8 sd rec 60.This report is 2 of 2 for (b)(4).

• Brand Name: 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 60
• 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): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12421635
• MDR Text Key: 269772939
• Report Number: 2939274-2021-05167
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982053817
• UDI-Public: (01)10886982053817
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.211.060
• Device Catalogue Number: 02.211.060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2021
• 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: 2.7/3.5 VA-LCP OLECRANON PL 4H/RT/116; UNK - SCREWDRIVERS: SHAFTS
• Patient Age: 59 YR