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

Catalog Number 03.632.036

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

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

Event Date 01/30/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information not available for reporting.Device is an instrument and is not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.Device history records review was conducted.The report indicates that the: dhr review for part# 03.632.036 lot# 9959561, release to warehouse date: 25apr2016, expiration date: n/a, 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 on (b)(6) 2017 during a l4-s1 posterior lumbar interbody fusion (plif) procedure involving matrix.After the surgeon had all of his screws successfully placed, he wanted to advance a couple of screws.When he was given the matrix t25 screwdriver and tried to advance the screws, the handle turned but the shaft remained stagnant.The glue or adhesive fixation holding the handle rigid to the shaft came loose allowing the handle to rotate without the shaft rotating.He tried using an additional matrix t25 screwdriver in the set and the same problem occurred.He was able to successfully advance the screws when he was given the matrix t25 t-handle.The procedure was completed successfully without patient harm.The entire implanted construct included six bone screws at l4, l5, and s1, six poly heads, six cobalt chrome caps and two 65mm titanium pre curved rods.Later during the case, the scrub technician was putting away the instruments in the operating room and noticed one of the matrix long holding sleeves was malformed.The top two threads of the driver had been lifted off from the rest of the threads creating a gap, but did not cause any fragments.The threads stayed attached to the tip of the driver but were unusable for future cases.This did not cause a problem for this case and was not noticed until after the case was successfully completed.This complaint involves three devices.Concomitant devices reported: bone screw (part# 04.639.750, lot# unknown, quantity 2); bone screw (part# 04.639.755, lot# unknown, quantity 2); bone screw (part# 04.639.750, lot# unknown, quantity 2); poly heads (part# unknown, lot# unknown, quantity 6) this report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device returned may 22, 2017.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.

Manufacturer Narrative

An evaluation was performed on the returned matrix holding sleeve.The two t25 stardrive shafts were not returned for the investigation purpose.The device history records for the stardrive shafts revealed that there were no potential issues during the manufacture of the product that would contribute to this complaint condition.No further investigation would be performed regarding the unreturned devices.Following device was received at complaint handling unit on 06/05/2017; holding sleeve-long for matrix: p/n 03.632.036, lot# 9959561.The matrix holding sleeve (part 03.632.036, lot 9959561) was returned with the top thread of the driver lifted off from the rest of the threads creating a gap, but not creating any fragments.The returned instrument was examined at customer quality and the complaint condition was able to be confirmed.A visual inspection, device history records review, and drawing review were performed as part of this investigation.A functional test is not applicable as the damage was visually confirmed.This complaint is confirmed.No new malfunctions were identified during the investigation.The matrix holding sleeve ¿ long is one of ten (10) holding sleeves for the matrix spine system utilized during screw insertion.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.Dhr review: 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.Relevant product drawings were reviewed: od of the threaded tip could not be verified due to deformation of the feature.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.Based on the available information it is not possible to determine a definitive root cause for the complaint condition.Considering the way the sleeve is used during surgery it is possible that the threading on the distal tip was damaged due to being used while not being fully threaded into pedicle screws or due to off-axis load while engaging a screw.It is also possible that the tip of the sleeve was damaged due to rough handling during use and/or sterile processing and the cumulative effect eventually contributing to the 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.

Manufacturer Narrative

Statement in device evaluation stated, ¿following device was received at complaint handling unit on 06/05/2017¿ should have read, ¿following device under (b)(4) was received by cq engineering on 06/06/2017¿.Device was received by manufacturer on 5/22/2017, received by evaluating engineers on 6/06/2017.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: 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6351259
• MDR Text Key: 68114334
• Report Number: 1719045-2017-10134
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10705034718941
• UDI-Public: (01)10705034718941(10)9959561
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• 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: 9959561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2016
• 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
• Treatment: BONE SCREW (PART# 04.639.750, LOT# UNKNOWN, QTY 2; BONE SCREW (PART# 04.639.755, LOT# UNKNOWN, QTY 2; POLY HEADS (PART# UNKNOWN, LOT# UNKNOWN, QTY 6