MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4 VA 2-COL DRP NRW 6H HD/3H SFT/RT-S; PLATE, FIXATION, BONE

Model Number 02.111.530S

Device Problem Device-Device Incompatibility (2919)

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

Event Date 05/11/2022

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 on (b)(6) 2022 during an orthopedic procedure, the screws would not lock in 2 variable angle (va) distal radius plates.Multiple locking buttress pins and locking screws were tried on 2 different plates.They could not get the locking screws to engage the plate.A screw in drill guide would lock in correctly however, eventually a 6 hole lcp volar column plate was used that worked fine.Additional x-rays were taken.There was a surgical delay of more than 30 minutes.The procedure completed successfully.There was no patient consequence reported.This is report 1 of 11 for pc-(b)(4).This report is for a va plate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: product code: 02.111.530s.Lot number: 544p193.Manufacturing site: mezzovico.Release to warehouse date: 21-dec-2021.Expiration date: 30-nov-2031.A manufacturing record evaluation was performed for the sterile lot number, and no nonconformances were identified.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that there was no damage or defects with the 2.4 va 2-col drp nrw 6h hd/3h sft/rt-s.A dimensional inspection was performed for the 2.4 va 2-col drp nrw 6h hd/3h sft/rt-s was unable to be performed due to the complex geometry of the device.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the 2.4 va 2-col drp nrw 6h hd/3h sft/rt-s was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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.

• Brand Name: 2.4 VA 2-COL DRP NRW 6H HD/3H SFT/RT-S
• 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): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14600997
• MDR Text Key: 295866798
• Report Number: 2939274-2022-02089
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982031761
• UDI-Public: (01)10886982031761
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.111.530S
• Device Catalogue Number: 02.111.530S
• Device Lot Number: 544P193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 1.8 VA LCKNG BUTTRESS PIN T8 SD REC/18; 1.8 VA LCKNG BUTTRESS PIN T8 SD REC/20; 2.4 CORTEX SCREW SLF-TPNG T8 SD REC 10; 2.4MM VA LOCKING SCREW SDDRIVE 10MM
• Patient Age: 73 YR
• Patient Sex: Female