MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RADIOLUCENT INSERTION HANDLE FRN; ROD, FIXATION, INTRAMEDULLARY

Model Number 03.033.001

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Reporter is a sales representative.The device has been received, the investigation is in progress, 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 that on (b)(6) 2020, the insertion handle was found in sterile processing with a piece of metal stuck in the insertion handle, and the driving cap will not screw in it, which makes it unusable and defective.No patient involvement.This report is for 1 radiolucent insertion handle frn.This is report 1 of 1 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6 investigation summary.Visual inspection: the radiolucent insertion handle frn (p/n: 03.033.001, lot #: l849566) was returned and received at us cq.Upon visual inspection, it was observed that the broken distal tip of the mating device was struck/lodged within the threaded portion of the insertion handle but could be fully removed.Light surface wear was observed on the device but has no impact on the device functionality.No other issues were identified with the returned device.Functional test: a functional test was not performed as the device was returned by itself.Can the complaint be replicated with the returned device? unable to perform.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Document/specification review: based on the date of manufacture the following drawings, the current and manufactured revision of drawings were reviewed insertion handle asm.Complaint confirmed? yes, a metal piece was stuck inside the returned device.Hence confirming the allegation.Investigation conclusion the complaint condition was confirmed for the radiolucent insertion handle frn ( p/n: 03.033.001, lot #: l849566).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to the mating device broken during use with the insertion handle and the metal piece stuck inside not removed during the sterilization process.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 history part: 03.033.001.Lot: l849566.Manufacturing site: (b)(4).Release to warehouse date: (b)(6) 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformities were identified.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: RADIOLUCENT INSERTION HANDLE FRN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10221219
• MDR Text Key: 197295294
• Report Number: 2939274-2020-03060
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982271051
• UDI-Public: (01)10886982271051
• Combination Product (y/n): N
• PMA/PMN Number: K172157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.033.001
• Device Catalogue Number: 03.033.001
• Device Lot Number: L849566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1