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	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Part: 388.50; synthes lot: 5214365; supplier lot: a7pa13; release to warehouse date: april 07, 2006; manufacturing site: synthes (b)(4); supplier: (b)(4).No nonconformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.The customer reported the set screw was not long enough to stay on the track.The initial inspection of the device was completed on october 24, 2018.The repair technician reported that the collet was damaged.The cause of the issue is unknown.Service record router completed.Finalized service record will be archived.The device will be returned to the customer upon completion of the service and repair process.The evaluation was confirmed.During this investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Based on the investigation findings, 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.
Event or Problem Description
It was reported that during a routine inspection of instruments on (b)(6) 2018, it was noted that it was noted that the following instruments were found to have device issues.On the first rod introduction pliers for side-opening implants, its set screw in the part that slides up and down the tube is not long enough to keep it in the track.On the second rod introduction pliers, its ratchet does not hold during loading according to a note on the device, and the pliers might be bent.There were no procedure and patient involvement.This report is for a rod introduction pliers for side-opening implants.This is report 1 of 2 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.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.The customer reported the set screw was not long enough to stay on the track.The repair technician reported the collet was damaged.The cause of the issue is unknown.Attached service record router completed through operation 10.Tube, nut, collet and set screw were fixed at service center.The item was scrapped due to unknown reason and was forwarded to customer quality.The evaluation was confirmed.The device was received intact.There were no issues found.Since the device was already repaired at service center and scrapped for unknown reasons, the complaint can be confirmed for the reported condition.A review of manufacturing evaluation record showed that there were no issues during the manufacture of this product, and any sub components, which would contribute to this complaint condition.No definitive root cause was able to be determined as the circumstances surrounding the event are unknown.It is likely due to wear from repeated use over the lifetime of the multiple use devices.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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 history lot part number: 388.50, synthes lot number: 5214365, supplier lot number: a7pa13, release to warehouse date: 07-apr-2006, manufacturing site: synthes monument , supplier: (b)(4).Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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: 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: 8008859
• Report Number: 2939274-2018-54633
• Device Sequence Number: 16581160
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/30/2018

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: 5214365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 05/21/2019; 07/17/2019
• Initial Report FDA Received Date: 10/26/2018
• Supplement Report FDA Received Date: 06/19/2019; 07/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1