MAUDE Adverse Event Report: SYNTHES MONUMENT HOLDING SLEEVE-STANDARD; MISC ORTHO SURGICAL INSTRUMENT

Catalog Number 03.632.001

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

Patient Problem No Patient Involvement (2645)

Event Date 11/17/2015

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.(b)(6).Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records was conducted.The report indicates that the: wrong part number: it should be 03.632.001, manufacturing location: (b)(4), packaged by: (b)(4), manufacturing date: 12/06/2011, part #: 03.632.001, lot#: 6676660 (nonsterile).Quantity (b)(4).Lot was release to the warehouse on 12/06/2011.Purched order no: (b)(4) were issued on 12/16/2011.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

Report from synthes europe reports an event in (b)(6) as follows: it was reported that during a matrix case at the l4/l5 level, a t25 stardrive shaft and holding sleeve were not able to properly insert a matrix screw into the pedicle.It was found upon inspection that the t25 stardrive shaft was stripped and the holding sleeve was chipped.There was no report of fragments generated by the chipped holding sleeve.Another t25 stardrive shaft and holding sleeve were immediately available.There was no surgical delay reported.The procedure was completed successfully.No additional information was available.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

An investigation summary was performed.The investigation of the complaint articles has shown that:part (03.632.001 lot 6676660): it was reported that during an l4/l5 matrix procedure, the surgeon had difficulty inserting a polyaxial screw using a t25 stardrive shaft and holding sleeve.Inspection showed that the driver shaft was stripped and the holding sleeve had broken threads; no fragments were generated.There was no surgical delay as alternate instruments were immediately available.The returned instruments were examined and the complaint condition was able to be confirmed in each instance.The tip of the t25 stardrive shaft (03.632.002 lot 6968777) was found to be stripped and the threaded tip of the retain-sleeve (03.632.001 lot 6676660) was found to be broken and missing a distal piece (not returned).A definitive root cause is unable to be determined with the provided information however the failures are consistent with the application of excessive force, off-axis loading or over-threading.The returned instrument was examined and the complaint condition was able to be confirmed as a portion of the threaded tip of the instrument was found to be broken and not returned; the missing piece is approximately 1.5mm x 6mm (tip diameter) a definitive root cause is unable to be determined with the provided information, however the failure is consistent with the application of excessive force, off-axis loading or over-threading.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

(b)(4).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

Device report from synthes (b)(4) reports:.

• Brand Name: HOLDING SLEEVE-STANDARD
• 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: 5277736
• MDR Text Key: 33039710
• Report Number: 1719045-2015-10807
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.632.001
• Device Lot Number: 6676660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2011
• 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