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

Catalog Number 03.632.036

Device Problem Material Distortion (2977)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Dhr review for part number: 03.632.036, synthes lot number: 9907547, release to warehouse date: february 3, 2016, manufacturer site: (b)(4), supplier: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this 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 of the tip of the matrix holding sleeve are damaged.This was discovered while doing an instrument maintenance check in sterile processing.It is not known when the threads became damaged.It is not known if the damaged thread generated any fragments.There was no reported patient or procedure involvement or harm when the damaged threads were noticed.This is report number 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device (matrix holding sleeve ¿ long, part number 03.632.036, lot number 9907547).The subject device was received for investigation with the complaint that the subject device was found to be broken during set inspection; no reported surgical or patient involvement.The matrix holding sleeve - long (03.632.036) is one of ten (10) holding sleeves for the matrix spine system utilized during screw insertion (03.632.001, 03.632.024, 03.632.028, 03.632.036, 03.616.042, 03.616.043, 03.632.085, 03.632.123, 03.632.124 and sd03.632.123).The matrix system is covered by three technique guides: matrix ¿ deformity, matrix-degenerative and matrix ¿ mis.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.The returned device was examined and the complaint condition was able to be confirmed as the threaded tip of the device was broken and missing a fragment (approximately 5.5mm x 3mm x 1.5mm ¿ calipers ca94).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.Relevant drawings for the returned devices were reviewed (both current revision and from the time of manufacture): top-level and inner shaft.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 mrrs, ncrs or complaint-related issues were identified with the lot number which may have contributed to the complaint conditions.Changes during april 2011 were implemented to address the failure mode of the holding sleeve threaded tips breaking.The tip geometry on the inner sleeve was changed to a more constant outer diameter in order to improve product performance; the returned instrument was manufactured after the implementation of these changes (mfg date 03-feb-2016).During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.No product design issues or discrepancies were observed.This complaint is confirmed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5742484
• MDR Text Key: 47958917
• Report Number: 1719045-2016-10503
• 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,Followup
• Report Date: 06/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• 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: 9907547
• Other Device ID Number: (01)10705034718941(10)9907547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2016
• 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