MAUDE Adverse Event Report: SYNTHES MONUMENT HOLDING SLEEVE-LONG FOR MATRIX; MISC ORTHO SURGICAL INSTR

Catalog Number 03.632.036

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.No known patient involvement.Unknown when breakage occurred.Device is an instrument and is not implanted/explanted.Date complaint was identified as reportable device history review was completed; release to warehouse date: (b)(6) 2016.Expiration date: n/a supplier: (b)(6).No non-conformance records (ncrs) were generated during production.Review of device history records showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.A product development investigation was performed for the holding sleeve (part number 03.632.036, lot number 9907548).The subject device was returned with the complaint condition stating broken and missing a segment (approximately 5.5mm long x 1.5mm x 1mm¿ measured with calipers).The complaint was confirmed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint is confirmed.Relevant drawings for the returned matrix holding sleeves ¿ long (03.632.036) were reviewed.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.The calculated occurrence rates are acceptable under the system risk assessments no definitive root cause was able to be determined; the failure modes are consistent with the application of an off-axis load while engaging a screw.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 a routine set inspection on an unknown date, four (4) devices were found with device malfunctions.It was noted the threading appeared damaged on the tips on three (3) holding sleeves and a stardrive screwdriver tip also appeared damaged and worn.There is no case or patient involvement.On (b)(6) 2016 it was determined that one (1) holding sleeve and the stardrive screwdriver were found to be broken and each missing fragments and reportability was changed from non-reportable to reportable.This is report 1 of 2 for (b)(4).

• Brand Name: HOLDING SLEEVE-LONG FOR MATRIX
• Type of Device: MISC ORTHO SURGICAL INSTR
• 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: 6150711
• MDR Text Key: 61614759
• Report Number: 1719045-2016-10887
• Device Sequence Number: 1
• Product Code: LXH
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Catalogue Number: 03.632.036
• Device Lot Number: 9907548
• Other Device ID Number: (01)10705034718941(10)9907548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2016
• 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