MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4/2.7 VA-LCP 2-C DRP STD 6H HD/10H SHAFT/145MM/RT-STER; PLATE, FIXATION, BONE

Model Number	02.111.680S
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.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 or Problem Description
It was reported that during a procedure on (b)(6) 2022, the contour of the sterile xl distal radius plate didn¿t seem to match with the non-sterile variable angle (va) distal radius plate thus not fitting well for the patient.The standard va plate was used as a template.When the sterile plate was opened, the fit on bone no longer matched.The surgeon had to use another option.Procedure was completed with no delay.There was no reported patient consequence.This report is for a 2.4/2.7 va-lcp 2-c drp std 6h hd/10h shaft/145mm/rt-ster.This is report 1 of 1 for (b)(4).
Additional 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d4: lot and expiration date d9.H3, h4, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.
Additional 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.G3: device received on 29-april-2022.H3, h6: device evaluated.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 2.4/2.7va 2c drp st 6h hd/10h sft/145r-s (product code: 02.111.680s lot number:34p8668).Mating device was not returned.Functional test could not be performed.A dimensional inspection was performed for the 2.4/2.7va 2c drp st 6h hd/10h sft/145r-s (product code: 02.111.680s lot number:34p8668) and met specifications.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 2.4/2.7va 2c drp st 6h hd/10h sft/145r-s (product code: 02.111.680s lot number:34p8668) 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.A manufacturing record evaluation was performed for the sterile lot number, and no non-conformances were identified.Product code: 02.111.680s-us.Lot number: 34p8668.Manufacturing site: mezzovico.Release to warehouse date: 24 jan 2020.Expiration date: 01 dec 2029.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: 2.4/2.7 VA-LCP 2-C DRP STD 6H HD/10H SHAFT/145MM/RT-STER
• Common Device Name: 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: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13827913
• Report Number: 2939274-2022-00971
• Device Sequence Number: 11300175
• Product Code: HRS
• UDI-Device Identifier: 10886982032164
• UDI-Public: (01)10886982032164
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K163046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.111.680S
• Device Catalogue Number: 02.111.680S
• Device Lot Number: 34P8668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 04/27/2022; 04/29/2022
• Initial Report FDA Received Date: 03/19/2022
• Supplement Report FDA Received Date: 05/26/2022; 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - PLATES: VA-LCP DISTAL RADIUS.
• Patient Sex: Unknown