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

Model Number 03.010.024

Device Problem Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.A review of the device history record has been requested.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 that on an unknown date, during routine incoming inspection of loaner set it was observed that the holding device for guide wires and reaming rods would not release.There was no patient involvement.This complaint involves one (1) device.This report is 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.Initial reporter is a synthes employee.Part: 03.010.024; lot: t144416; manufacturing site: tuttlingen; release to warehouse date: may 08, 2017.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the device was delivered in one sealable bag.The device appears in a good condition, however the device is damaged at one edge on the handle.It most likely fell to the ground.Functional test: if the lever is not triggered, the locking mechanism is working.If the lever is activated the locking mechanism is slightly hard to release.For an easy release of the locking function, the lever needs to be pushed to the limit stop.Upon further investigation, it was noticed that the mechanism is too dry.A drop of oil was added, after that releasing of the locking mechanism is working correctly.Upon investigation, the returned device had functional issues consistent with the complaint.Dimensional inspection: dimensional inspection was not performed because after adding a drop of oil the device worked properly.Manufacturing record evaluation: the holding device for guide wires and reaming rods was manufactured at the tuttlingen site on may 08, 2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Conclusion: the complaint is confirmed.The manufacturing evaluation conducted shows that there were no issues during the manufacture of the product that would contribute to this complaint condition.The exact cause of the holding device not releasing cannot be determined.The mechanism was probably too dry due to the cleaning / sterilizing of the device and got stuck.Furthermore, the fact that the device probably fell to the ground could have caused this issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: HOLDING DEVICE FOR GUIDE WIRES AND REAMING RODS
• Type of Device: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8804604
• MDR Text Key: 151706585
• Report Number: 2939274-2019-59258
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10886982067005
• UDI-Public: (01)10886982067005
• 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
• Type of Report: Initial,Followup
• Report Date: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• 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
• Device Lot Number: T144416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Date Manufacturer Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1