MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/6 HOLES/LEFT; PLATE, FIXATION, BONE

Model Number 02.118.205

Device Problems Contamination /Decontamination Problem (2895); Device-Device Incompatibility (2919)

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

Event Date 07/25/2022

Event Type  malfunction  

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.Additional procode: hwc.Occupation: initial reporter is a synthes employee.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.

Event Description

It was reported that on 25-july-2022, the sales rep was putting the devices together and noticed significant differences in the finishes.The finishing on the antero lateral and distal fibula plates do not look conforming when compared to the smooth finishing of the medial distal plate.It was reported as looking like there was a water mark that could not be rubbed off.There was no reported patient consequence.No further information is available.This report is for a 2.7/3.5mm va-lcp anterolateral distal tibia pl/6 holes/left.This is report 2 of 2 for (b)(4).

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: h3, h6: part: 02.118.205-us; lot: 897p983; part manufacture date: 30 june 2022; manufacturing location: elmira; part expiration date: n/a; nonconformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 2.7/3.5mm va-lcp anterolateral distal tibia pl/6 holes/left product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual, and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.The product was returned to depuy synthes and sent to manufacturing site: jabil elmira for evaluation.The jabil elmira team conducted a visual inspection of the returned device.Visual analysis of the returned sample was performed on 2.7/3.5 va anterolat dstl tib pl/6 h/lft.The returned device was received loose in a bag and laser etched part number 02.118.205 plate, batch 897p983.A visual inspection of the 2.7/3.5mm va-lcp anterolateral distal tibia pl/6 holes/left shows the plate appears to be in the same acceptable conforming condition cosmetically per inspection sheet and top-level drawing as it was when it shipped from the jabil elmira manufacturing facility.Per inspection sheet used for final inspection of the 02.118.205 plate, a 100% cosmetic inspection was performed at normal reading distance, understanding and using visual standards, on batch 897p983 prior to release of product to the warehouse.During the evaluation of the 02.118.205 plate involved in this complaint, the quality engineer determined the plate was in acceptable conforming condition.The available data does not support the complainant¿s description of the complaint condition, and there is no evidence to support the allegation made in the complaint.The complaint condition is unconfirmed or could not be confirmed based on the available data.A dimensional inspection was performed for the 2.7/3.5 va anterolat dstl tib pl/6 h/lft 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 for the 2.7/3.5 va anterolat dstl tib pl/6 h/lft.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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: 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/6 HOLES/LEFT
• 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): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15266375
• MDR Text Key: 305419210
• Report Number: 2939274-2022-03284
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982038364
• UDI-Public: (01)10886982038364
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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
• Device Operator: Health Professional
• Device Model Number: 02.118.205
• Device Catalogue Number: 02.118.205
• Device Lot Number: 897P983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2022
• Initial Date FDA Received: 08/22/2022
• Supplement Dates Manufacturer Received: 09/21/2022
• Supplement Dates FDA Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 2.7 VA-LCP LATERAL DSTL FIB PL/7 H/RT.