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

Catalog Number 03.632.036

Device Problems Break (1069); Material Deformation (2976); Material Distortion (2977)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.No patient involvement reported.Device is an instrument and is not implanted/explanted.Subject device has been received and an investigation summary was performed.The investigation of the complaint articles has shown that: it was reported that the tip of a matrix holding sleeve ((b)(4) lot 6778549 mfg.05-jan-2012) was found to be damaged during set inspection; no patient or surgical involvement.The returned device was examined and the complaint condition was able to be confirmed as the threaded tip was found to be broken and missing a segment (approximately 6.5mm x 4.5mm x 1.5mm ¿ calipers (b)(4)).Once the holding sleeve is engaged with the driver shaft, it can be threaded into the proximal end of the matrix screw by rotating the holding sleeve¿s green knob clockwise until it is fully engaged.No definitive root cause was able to be determined; the failure mode is consistent with the application of an off-axis load while engaging a screw.The returned device was examined and the complaint condition was able to be confirmed as the threaded tip was found to be broken.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition device history records was conducted.The report indicates that the: manufacturing location: supplier - (b)(4), packaged :(b)(4), manufacturing date: 05-jan-2012 part #: (b)(4), lot#: 6778549 (non-sterile) - holding sleeve-long for matrix.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 the threads on the tip of the holding sleeve are damaged.The issue was found during a routine inspection in preparation for an upcoming case.No issues with the device prior to discovery.There is no patient or case involvement.No additional information.There is 1 part in this complaint.This report is 1 of 1 for (b)(4).

• Brand Name: HOLDING SLEEVE-LONG FOR MATRIX
• Type of Device: MISC ORTHO SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5648397
• MDR Text Key: 45046772
• Report Number: 1719045-2016-10385
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2016

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: Health Professional
• Device Catalogue Number: 03.632.036
• Device Lot Number: 6778549
• Other Device ID Number: (01)10705034718941(10)6778549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/25/2016
• Initial Date FDA Received: 05/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2012
• 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