MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC INSERTN HANDLE F/3.5MM LOW BND MEDIAL DISTAL TIB PLATE/RIGHT; GAUGE,DEPTH

Catalog Number 03.113.025

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No patient involvement reported.Date of event is unknown.Device is an instrument and is not implanted/explanted.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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

(b)(6) reported following: it was reported that while going through the washing machine during sterilization, the screw that tightens the insertion handle to the aiming arm must have loosened.It was lost and could not be located.There was no surgery or patient involvement.This report is for one (1) insertn handle f/3.5mm low bnd medial distal tib plate/right.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6: dhr review was completed.Part: 03.113.025 , lot: l065951 , manufacturing site: hägendorf , release to warehouse date: 11.November 2016.The device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.H3, h6: service and repair conducted an evaluation of the returned device.The customer reported the set screw was missing.The repair technician reported the screw was missing.Missing parts is the reason for repair.The cause of the issue is unknown.The following parts were replaced: m3.5 screw.The item was repaired per the inspection sheet, passed synthes final inspection on 27-jun-2018 and will be returned to the customer upon completion of the service and repair process.Service record router completed through operation 30.Finalized service record will be archived in document management system.The evaluation was confirmed.The device was deemed serviceable and returned to the customer.No design or manufacturing issues were identified; therefore, it has been determined that no corrective and/or preventative action is proposed.D10: date returned to manufacturer.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.

• Brand Name: INSERTN HANDLE F/3.5MM LOW BND MEDIAL DISTAL TIB PLATE/RIGHT
• Type of Device: GAUGE,DEPTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7542471
• MDR Text Key: 109237766
• Report Number: 2939274-2018-52308
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982072917
• UDI-Public: (01)10886982072917
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.113.025
• Device Lot Number: L065951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Date Manufacturer Received: 07/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1