MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.7MM CABLE WITH CRIMP 750MM-STERILE; CERCLAGE FIXATION

Model Number 298.801.01S

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Non-union Bone Fracture (2369)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Event year is reported as 2021; however exact date of event is unknown.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The 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.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 an unknown date, during a removal procedure, the plate was removed due to bone healing failure.This was implanted on (b)(6) 2021.Patient outcome is unknown.This complaint involves ten (10) devices.This report is for (1) 1.7mm cable with crimp 750mm-sterile this report is 8 of 10 for (b)(4).

• Brand Name: 1.7MM CABLE WITH CRIMP 750MM-STERILE
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12505397
• MDR Text Key: 272442770
• Report Number: 1833824-2021-00074
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 10886982182500
• UDI-Public: (01)10886982182500
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 298.801.01S
• Device Catalogue Number: 298.801.01S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 4.5 LCP PROXIMAL FEMUR PL 8H/247/RT-S; 4.5 THRD CERCLAGE POSITIONING PIN-SILE; 4.5MM CORTEX SCREW SELF-TAPPING 38MM; 4.5MM CORTEX SCREW SELF-TAPPING 50MM; 5.0 LCKNG SCREW SLF-TPNG T25 SD REC 16; 5.0MM CANNULATED LOCKING SCREW 120MM; 7.3MM CANNULATED LOCKING SCREW 80MM
• Patient Outcome(s): Required Intervention