MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HOLDING DEVICE FOR GUIDE WIRES AND REAMING RODS; SCREWDRIVER

Model Number 03.010.024

Device Problem Device-Device Incompatibility (2919)

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

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that the hindfoot arthrodesis nail set - underwent tray audit and preventative maintenance.The instruments require replacement as the entire aiming arm seems to be missing the nail during drilling/screw insertion.No patient consequences reported.No further information provided.This report is for one (1) holding device for guide wires and reaming rods.This is report 1 of 5 for (b)(4).

• Brand Name: HOLDING DEVICE FOR GUIDE WIRES AND REAMING RODS
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 11101740
• MDR Text Key: 224601936
• Report Number: 2939274-2020-05802
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10886982067005
• UDI-Public: 10886982067005
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.010.024
• Device Catalogue Number: 03.010.024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: AIMING ARM FOR TI CANN HINDFOOT ARTHRODESIS NAIL; HANDLE WITH MINI QUICK COUPLING; INSERTION HANDLE F/HINDFOOT ARTHRODESIS NAIL; THREADED ALIGNMENT PIN F/HINDFOOT ARTHRODESIS NAIL; THREADED ALIGNMENT PIN F/HINDFOOT ARTHRODESIS NAIL