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

Model Number 03.037.012

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/ investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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, during a trochanteric femoral nailing advanced (tfna) procedure intramedullary (im) nailing of femur, the set screw was not put down, and instead reversed until it bound itself against the connecting screw of the tfna insertion handle.Consequently, the surgeon planned to leave it as is, but when attempting to remove the connecting screw, it would not budge.As a result, the tfna screw was removed (no 5.0mm locking screw was used) and trochanteric femoral nailing advanced (tfna) nail (still attached to the insertion handle) was removed.Then a new nail was opened and attached to a tfna hybrid handle.Surgeon reinserted the nail and finished the procedure with no further problems.Now the old nail is stuck to the insertions handle for tfna.The procedure was successfully completed with thirty (30) minutes surgical delay reported.No patient consequence reported.This report is for one (1) complete radiolucent insertion handle.This is report 2 of 3 for complaint (b)(4).

• Brand Name: COMPLETE RADIOLUCENT INSERTION HANDLE
• 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
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12350484
• MDR Text Key: 267646109
• Report Number: 2939274-2021-04786
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982070289
• UDI-Public: (01)10886982070289
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.037.012
• Device Catalogue Number: 03.037.012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 10 YR
• Patient Weight: 42