MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5 VA-LCP CURVED COND PL/14 HOLE/301/RT; PLATE, FIXATION, BONE

Model Number 02.124.414

Device Problem Device-Device Incompatibility (2919)

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

Event Type  malfunction  

Event Description

During a femur orif with the va condylar system, the surgeon was attempting to assemble the percutaneous aiming arm to the 14-hole right plate and found that the connection was not secure.The locking bolt for the aiming arm would screw into the connecting locking hole of the plate but would pull out once the locking nut was assembled.In order to determine whether the instrument or the plate hole was faulty, the surgeon attempted to assemble the aiming arm to the 16-hole and found that it connected tightly and securely.Therefore, it was determined that the threaded locking hole of the 14-hole plate must have been damaged or faulty.There was a 2-minute delay as a result, but no patient consequence.The 16-hole plate was used instead and the surgery was completed successfully.No photo available.This complaint involves one (1) device 4.5 va-lcp curved cond pl/14 hole/301/rt.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

(b)(4).Additional product code: hwc screw, fixation, bone.Jdp condylar plate fixation implant.Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history record has been completed.A manufacturing record evaluation was performed for the not sterile lot number, and no non-conformances were identified.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.

Manufacturer Narrative

(b)(4).Additional product code: hwc screw, fixation, bone.Jdp condylar plate fixation implant.Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history record has been completed.A manufacturing record evaluation was performed for the not sterile lot number, and no non-conformances were identified.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

During a femur orif with the va condylar system, the surgeon was attempting to assemble the percutaneous aiming arm to the 14-hole right plate and found that the connection was not secure.The locking bolt for the aiming arm would screw into the connecting locking hole of the plate but would pull out once the locking nut was assembled.In order to determine whether the instrument or the plate hole was faulty, the surgeon attempted to assemble the aiming arm to the 16-hole and found that it connected tightly and securely.Therefore, it was determined that the threaded locking hole of the 14-hole plate must have been damaged or faulty.There was a 2-minute delay as a result, but no patient consequence.The 16-hole plate was used instead and the surgery was completed successfully.No photo available.This complaint involves one (1) device 4.5 va-lcp curved cond pl/14 hole/301/rt.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 4.5 VA-LCP CURVED COND PL/14 HOLE/301/RT
• Type of Device: PLATE, FIXATION, BONE
• 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: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13584030
• MDR Text Key: 286137696
• Report Number: 2939274-2022-00605
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982042897
• UDI-Public: 10886982042897
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.124.414
• Device Catalogue Number: 02.124.414
• Device Lot Number: 162P780
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2021
• Is the Device Single Use?: No
• Patient Sequence Number: 1