MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC VICE GRIP, LENGTH 180 MM; PLIERS,SURGICAL

Model Number 391.88

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.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

Device report from synthes reports an event in (b)(6) as follows: it was reported a customer has a number of instruments that are not functioning correctly.Locking pliers has a jaw has limited range of motion and also cannot lock.A t-handle, quick coupling is not gripping onto tap properly.A countersink screwdriver is chipped with a warped screw head.No patient or surgical involvement.This is report 1 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.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.

Manufacturer Narrative

Product complaint # (b)(4).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.E1: reporters state: (b)(6).H3, h4, h6: a review of the device history record part number: 391.88.Lot number: t159103.Manufacturing site: tuttlingen.Release to warehouse date: 09-may-2018.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.H3, h6: service and repair evaluation the customer reported the device's jaw has limited range of motion, also cannot lock.The item passed testing per the inspection sheet and worked within normal parameters.The complained issue was not able to be reproduced.The cause of the complained issue is unknown.The item passed synthes final inspection on 18-oct- 2019 and will be returned to the customer upon completion of the service and repair process.Attached service record router completed through operation 30.Finalized service record will be archived in tungsten document management system.The evaluation was unconfirmed.The device will be returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.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: VICE GRIP, LENGTH 180 MM
• Type of Device: PLIERS,SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9108825
• MDR Text Key: 191533242
• Report Number: 2939274-2019-60818
• Device Sequence Number: 1
• Product Code: HTC
• UDI-Device Identifier: 10886982198334
• UDI-Public: (01)10886982198334
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/28/2019

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: 391.88
• Device Catalogue Number: 391.88
• Device Lot Number: T159103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Initial Date Manufacturer Received: 08/28/2019
• Initial Date FDA Received: 09/24/2019
• Supplement Dates Manufacturer Received: 10/04/2019; 10/25/2019
• Supplement Dates FDA Received: 10/22/2019; 11/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1