MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CABLE TENSIONER; : MISC ORTHO SURGICAL INSTRUMENT

Model Number 391.201

Device Problem Device Difficult to Maintain (3134)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2019

Event Type  malfunction  

Manufacturer Narrative

The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.A review of the device history records has been requested.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventive 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.

Event Description

It was reported that on (b)(6) 2019, the patient underwent hip revision surgery, the cable tensioner would not tension cable.Stem replaced and cables were used around femur.The surgeon was able to successfully put cables on.Procedure was successfully completed with no surgical delay.Patient status is okay.This complaint involves one (1) device.

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.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

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 that the cable tensioner would not tension cable.The repair technician reported that the device is not functioning properly.Warranty replaced is the reason for repair.The item is not repairable per the inspection sheet and the supplier is not able to repair as its on the exclusion list.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.Product description: tensioner, cable.Synthes depuy synthes part number: 391.201, rti surgical part number: 400-81 o, lot number: p507840, manufacture date: 2/07/2002, depuy synthes po number: 275263, rti notification number: 200025371.Shortly after this complaint was filed, it was confirmed that the device would not be returned to rti surgical for evaluation.Inspections could not be conducted as the device was not returned to rti surgical.This complaint investigation will be updated should the device be returned at a later date.A dhr review was conducted and found that the device met manufacturing specification prior to shipping.Further investigation will not be performed at this time as the risk associated with this occurrence is low for both patient and user.Visual inspection performed on the returned device at customer quality showed no visual defects.And cable is jammed on the instrument.Functional testing was performed at service and reapir and stated: device is not functioning properly.A dimensional inspection could not be performed as the internal features could not be assessed without damaging the instrument further.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.The complaint condition is confirmed and a root cause could not be definitely determined given the unknown circumstance.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot part number: 391.201, synthes lot number: p507840, supplier lot number: n/a, release to warehouse date: 22mar2002.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.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: CABLE TENSIONER
• Type of Device: : MISC ORTHO SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8537861
• MDR Text Key: 142782843
• Report Number: 2939274-2019-57603
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886982198204
• UDI-Public: (01)10886982198204
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2019

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: 391.201
• Device Catalogue Number: 391.201
• Device Lot Number: P507840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Initial Date Manufacturer Received: 03/27/2019
• Initial Date FDA Received: 04/22/2019
• Supplement Dates Manufacturer Received: 04/09/2019; 06/14/2019
• Supplement Dates FDA Received: 05/06/2019; 07/10/2019
• Patient Sequence Number: 1
• Patient Age: 79 YR