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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/12/2021

Event Type  malfunction  

Manufacturer Narrative

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) 2021, patient underwent an orthopedic procedure.The surgeon was inserting a rt femoral recon nail, while inserting the nail the driving cap sheared off and fell on the floor.The threaded portion broke off in the insertion handle.The surgeon used a screwdriver to finish inserting the nail without delay and completed the case without any further issues.No fragments generated and no patient consequences noted.This report involves one (1) radiolucent insertion handle frn.This is report 2 of 2 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: h3, h4, h6- the complaint condition was not confirmed as no damage were observed on the radiolucent insertion handle frn (p/n: 03.033.001, lot # 5p3869).There is no indication that a design or manufacturing issue were identified.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 number: 03.033.001 lot number: 5p3869 part/lot combination is unknown at jabil (in epr sap p02), no dhr review possible for group "synthes trauma - mfg - dhr - hagendorf".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
• Manufacturer (Section G): BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12591770
• MDR Text Key: 275242712
• Report Number: 2939274-2021-05953
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982271051
• UDI-Public: (01)10886982271051
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/12/2021

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: 03.033.001
• Device Catalogue Number: 03.033.001
• Device Lot Number: 55P3869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2021
• Initial Date FDA Received: 10/07/2021
• Supplement Dates Manufacturer Received: 10/29/2021
• Supplement Dates FDA Received: 11/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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: DRIVING CAP F/INSERTION HANDLE; UNK - NAILS: FEMORAL; DRIVING CAP F/INSERTION HANDLE; UNK - NAILS: FEMORAL
• Patient Age: 20 YR
• Patient Sex: Male