MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BOLT FOR FEMORAL NECK SYSTEM 95MM LENGTH-STERILE; APPLIANCE, FIXATION, NAIL

Model Number 04.168.295S

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

Patient Problems Cyst(s) (1800); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Part: 04.168.295s, lot: l942452, manufacturing site: (b)(4), release to warehouse date: july 02, 2018, expiry date: may 31, 2028.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.Product was not returned.Based on the information available, it has been determined that no corrective and 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.(b)(4).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 patient underwent removal of the femoral neck system (fns) devices and subsequent total hip arthroplasty due to hip pain and cystic changes.Initially, the reported devices were implanted on (b)(6) 2019 due to a femoral neck fracture.None of the reported devices were broken; they came out very easy and did not result in any further complications.Procedure was completed successfully.This report is for a bolt for femoral neck system.This is report 1 of 4 for (b)(4).

• Brand Name: BOLT FOR FEMORAL NECK SYSTEM 95MM LENGTH-STERILE
• Type of Device: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10852639
• MDR Text Key: 216663319
• Report Number: 2939274-2020-05185
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 10886982274755
• UDI-Public: (01)10886982274755
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172872
• 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: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.168.295S
• Device Catalogue Number: 04.168.295S
• Device Lot Number: L942452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 5.0MM TI LOCKING SCREW 44MM-STERILE; ANTIROTATION SCREW FOR FNS 100MM - STERILE; FEMORAL NECK SYSTEM PLATE 1 HOLE - STERILE
• Patient Outcome(s): Required Intervention
• Patient Weight: 67