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

Model Number 03.033.001

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary background: 9/2/2020: updated event description: it was reported that on (b)(6) 2020, during standard insertion of our frn nail, the nail was not going in easily and they were impacting nail with proper technique and the driving cap/threaded impactor broke off in the radiolucent insertion handle for frn.The nail was stuck and needed to be removed for additional reaming.The surgeons did not want to remove handle from the nail while it was stuck in the femur so the attempted to drive the nail our retrograde by using the hammer guide as an impactor against the radiolucent insertion handle.This was not successful, and it damaged the threaded end of the hammer slide such that it could not be used in normal fashion.The decision was then made to disconnect the handle from the nail and extract nail with extraction bolt which was successful.The femur was reamed larger and the nail was re-inserted with the same fnr insertion handle using the broken impactor to seat the nail.The re-insertion was successful, and the case was completed without further incident.Approximately 30 minutes was taken to attempt the nail removal without taking the insertion handle off.Patient survived the femoral rodding procedure successfully.No other medical intervention needed.There was 45 minutes surgical delay.Procedure successfully completed.No patient consequence.This complaint involves four (4) devices.Investigation flow: damage/visual.Visual inspection: the radiolucent insertion handle frn (part #: 03.033.001, lot #: 4l07484) was received at us cq.Upon visual inspection, it was observed that the threaded tip of the mating device (part #: 03.010.523, pi: (b)(6).Was stuck inside the insertion handle and could not be fully removed.The device also had surface scratches consistent with cumulative wear due to repeated product use.No other issues were identified with the device.Device failure/defect identified? no.Dimensional inspection: no dimensional inspection could be performed due to device geometry.Document/specification review: (b)(4) (manufactured and current) was reviewed.No design issues or discrepancies were identified.Complaint confirmed? no.Investigation conclusion: this complaint was not confirmed as the device was not found to be broken.However, surface scratches were observed on the device.There was no indication that a design or manufacturing issue contributed to the complaint so no definitive root cause could be determined based on the provided information.No design issues were observed during the document/specification review.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 lot: part: 03.033.001, lot: 4l07484, manufacturing site: (b)(4), release to warehouse date: 24.Jul.2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.Device history batch: null.Device history review: null.

Event Description

It was reported that on (b)(6) 2020, during standard femoral recon nail (frn) insertion procedure, the nail was not going in easily.As the nail was being impacted with proper technique, the driving cap/threaded broke off in the radiolucent insertion handle for frn.The nail was stuck and needed to be removed for additional reaming.The surgeons did not want to remove handle from the nail while it was stuck in the femur so they attempted to drive the nail out by using the hammer guide as an impactor against the radiolucent insertion handle.This was not successful and it damaged the threaded end of the hammer slide such that it could not be used in normal fashion.The decision was then made to disconnect the handle from the nail and extract nail with extraction bolt which was successful.The femur was reamed larger and the nail was re-inserted with the same fnr insertion handle using the broken impactor to seat the nail.The re-insertion was successful and the case was completed without further incident.Approximately thirty (30) minutes were taken to attempt the nail removal without taking the insertion handle off.No other medical intervention needed.There was forty-five (45) minutes surgical delay.Procedure was successfully completed.No patient consequences reported.Concomitant devices reported: driving cap threaded (part # 03.010.523, lot # 4l85186, quantity 1); radiolucent insertion handle frn (part # 03.033.001, lot # 4l07484, quantity 1), hammer guide (part # 03.010.170, lot # l750813, quantity 1).This report is for one (1) radiolucent insertion handle frn.This is report 3 of 3 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: 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 AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10607471
• MDR Text Key: 209227893
• Report Number: 2939274-2020-04396
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• 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: 4L07484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Date Manufacturer Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DRIVING CAP/THREADED; HAMMER GUIDE; UNK - NAILS; DRIVING CAP/THREADED; HAMMER GUIDE; UNK - NAILS
• Patient Weight: 73