MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS; PLIERS, SURGICAL

Model Number	388.50
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no known reported patient involvement associated with the complained event.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 on an unknown date, a rod introduction plier for side-opening implant tube was rotated and the sleeve (holds the collar implant) that slides up and down the "tube" got jammed on the tube during a routine inspection of consignment instrument sets.The set screw that keeps the sleeve in an open track on the tube was too short and does not go into the track far enough.There was no patient and procedure involvement.This report is for one (1) rod introduction pliers for side-opening implants.This is report 1 of 1 for complaint (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.A device history record (dhr) review was conducted.Part number: 388.50 , synthes lot number: 3914478 , supplier lot number: a7ha29 , release to warehouse date: 28-jan-1999 , expiration date: n/a , manufactured by synthes diener gmbh.No non-conformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Service & repair history: no service history review can be performed as part number 388.50 with lot number(s) 3914478/a7ha29 is a lot/batch controlled item.The service history review is unconfirmed.Please launch a dhr review.Service & repair evaluation: the customer reported the tube was rotated and the sleeve got jammed on the tube.The initial inspection of the device was completed on 16-oct-2018.The repair technician reported the tube slipped out of position.The cause of the issue is unknown.The device will be returned to the customer upon completion of the service and repair process.The evaluation was confirmed.The device was deemed serviceable and 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.
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.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
Inspection of consignment instrument sets occurred on (b)(6) 2018.

• Brand Name: ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS
• Common Device Name: PLIERS, SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7967044
• Report Number: 2939274-2018-54387
• Device Sequence Number: 1706570
• Product Code: HTC
• UDI-Device Identifier: 10705034773292
• UDI-Public: (01)10705034773292
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2018

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: 388.50
• Device Catalogue Number: 388.50
• Device Lot Number: 3914478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 11/27/2018; 11/28/2018
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 11/27/2018; 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1