MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11 TI CANN DISTAL FEMORAL NAIL 400-SILE; PIN, FIXATION, SMOOTH

Catalog Number 450.810S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Patient height reported as 188 centimeters.Exact date of event occurred; event occurred in 2022.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Part 450.810s, lot 4806054: release to warehouse date: july 13, 2004.Manufactured by: synthes monument.No non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 during total hip arthroplasty, the surgeon needed to remove a synthes distal femur nail and a proximal interlocking screw.The hardware was difficult to remove because of bony ingrowth.The hardware came out successfully, however the total hip was not performed.There were no consequences to the patient.This is report 1 of 2 for (b)(4).

Event Description

It was reported that postoperatively to a total hip arthroplasty, the surgeon needed to remove a synthes distal femur nail and a proximal interlocking screw.The hardware was difficult to remove because of bony ingrowth.The hardware came out successfully, however the total hip was not performed.There were no consequences to the patient.This is report 1 of 2 for (b)(4).

• Brand Name: 11 TI CANN DISTAL FEMORAL NAIL 400-SILE
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14435212
• MDR Text Key: 292017723
• Report Number: 2939274-2022-01773
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 10886982225344
• UDI-Public: (01)10886982225344
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970733
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 450.810S
• Device Lot Number: 4806054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2022
• Initial Date FDA Received: 05/19/2022
• Supplement Dates Manufacturer Received: 05/26/2022
• Supplement Dates FDA Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2004
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: NAIL LOCKING
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 130 KG