MAUDE Adverse Event Report: SYNTHES MONUMENT COUNTERTORQUE WRENCH FOR CSLP

Catalog Number 324.067

Device Problems Break (1069); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Part 324.067, lot uk7501: release to warehouse date: april 16, 2001.Supplier: (b)(4).Review of the device history record(s) showed there were no issues during the manufacture of the product that would contribute to the complaint condition.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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

It was reported that during inventory check on (b)(6) 2016, the countertorque wrench for cslp was found with one missing tooth.There is no reported patient or case involved.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Date received by manufacturer: entered sep 28, 2018 instead of sep 28, 2016 in error.Device 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

Additional narrative: product investigation was completed.One (1) countertorque wrench for cslp (part 324.067, lot uk7501, manufacturing date: apr 16, 2001) was returned with a complaint stating that a tooth was missing.There was no patient involvement.A visual inspection, device history record (dhr) review and drawing review were performed as part of this investigation.The complaint was able to be confirmed at customer quality as the instrument was returned with one of the distal teeth sheared off and the remaining three twisted counter-clockwise.No definitive root cause was able to be determined however the failure mode is consistent with a counter-clockwise rotational force and off-axis loading during use.The instrument is used as a countertorque to hold the expansion head screw in place while inserting the locking screw.Rotational force should not be applied to the instrument.The cslp technique guide states that the tips of the countertorque wrench (324.067) are intended to fit into the slots of the expansion head screw, and that the wrench itself should not be used for insertion and removal of expansion head screws.Relevant drawings for the returned instrument were reviewed (both from the time of manufacture and current revision).The design, materials and finishing processes were found to be appropriate for the intended use of this device.A device history review was performed for the returned instrument¿s lot number and no manufacturing records review, non conformances reports or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Device 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: COUNTERTORQUE WRENCH FOR CSLP
• Type of Device: WRENCH
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5893372
• MDR Text Key: 52737113
• Report Number: 1719045-2016-10629
• Device Sequence Number: 1
• Product Code: HXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2016

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: Medical Equipment Company Technician/Representative
• Device Catalogue Number: 324.067
• Device Lot Number: UK07501
• Other Device ID Number: (01)10705034769202(10)UK07501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/02/2016
• Initial Date FDA Received: 08/22/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/29/2016; 10/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2001
• 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