MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC MESH PLATE CUTTERS; INSTRUMENT, CUTTING, ORTHOPEDIC

Model Number 03.211.007

Device Problem Break (1069)

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

Event Date 01/30/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: reporter is a j&j sales representative.A review of the device history record has been completed.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

The mesh plate cutters (03.211.007) broke after single use on the 2.4 mm / 2.7 mm va-lcp mesh plate (02.211.224) during a foot surgery on (b)(6) 2022.The customer just purchased the mesh plate cutters and is frustrated they broke after single use.The nub that is inserted into the locking hole snapped off when applying tension.This report is for one (1) mesh plate cutters.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: reporter is a j&j sales representative.A review of the device history record has been completed.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

The mesh plate cutters (03.211.007) broke after single use on the 2.4 mm / 2.7 mm va-lcp mesh plate (02.211.224) during a foot surgery on (b)(6) 2022.The customer just purchased the mesh plate cutters and is frustrated they broke after single use.The nub that is inserted into the locking hole snapped off when applying tension.This report is for one (1) mesh plate cutters.This is report 1 of 1 for complaint (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: a product investigation was conducted.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Additionally, a visual inspection of the returned device was performed from attachment (broken mesh plate cutters.Jpg).Visual analysis of the returned sample revealed that the mesh plate cutters was found to have one of the positioning pins of the plate holder broken, fragment was not returned.A dimensional inspection for the mesh plate cutters was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the mesh plate cutters would contribute to the complained device issue.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.H3, h4, h6: a device history record (dhr) review was conducted: product code: 03.211.007.Lot number: 5l75784.Manufacturing site: jabil bettlach.Release to warehouse date: 11.October.2019.A manufacturing record evaluation was performed for the finished device lot and the non-conformance jbl-nr- was identified.A manufacturing record evaluation was performed for the finished device part: 03.211.007, lot: 5l75784, and no non-conformances related to the complaint condition were identified.The nonconformance referred within the dhr is a planned one, that was aimed to manage all work orders (wo)) which were in wip in bettlach site, during the cutover phase for the transition from old erp (sap p01) to the new erp (sap p02).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: MESH PLATE CUTTERS
• Type of Device: INSTRUMENT, CUTTING, ORTHOPEDIC
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13618880
• MDR Text Key: 286254653
• Report Number: 2939274-2022-00677
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10886982076052
• UDI-Public: (01)10886982076052
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,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

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.211.007
• Device Catalogue Number: 03.211.007
• Device Lot Number: 5L75784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1