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

Catalog Number 03.632.001

Device Problems Break (1069); Dull, Blunt (2407); Material Distortion (2977)

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

Event Type  malfunction  

Event Description

Report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that during a lumbar fusion procedure, the screw was loaded onto the matrix screwdriver (composed of the holding sleeve and screwdriver shaft).The surgeon attempted to insert the screw, and found that the screwdriver would not hold the screw.Upon further inspection the sleeve was found to be chipped and worn.Another screwdriver was available to use, and the surgery was completed with no reported patient or procedure harm; no reported surgical delay.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Unknown when device malfunctioned.Device is an instrument and is not implanted/explanted.(b)(6).Device history records was conducted.The report indicates that the: magnum manufacturing center (presently relias) manufactured the holding sleeve ¿ standard, for matrix, p/n 03.632.001, revision ¿j¿, lot # 6603333, per po # 1245328, dated september 26, 2011, for 49 parts.The certificate of compliance, dated september 24, 2011, indicates the parts were manufactured to the correct material requirements, met the hardness and required specifications, and conformed to p/n 03.632.001, revision ¿j¿.The parts were inspected and conformed to the synthes, tabulated incoming final inspection sheet number (b)(4), revision ¿n¿.There were no complaint-related issues, mrrs, or ncrs associated with these lots.Forty-nine parts were released to the warehouse on (b)(4) 2011.The lot was also inspected per the documented inspection results, dated october 29, 2010, the synthes data sheets (dated (b)(4) 2011) and the post ep sheets (dated (b)(4) 2011).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A device evaluation investigation was performed: the holding sleeve (03.632.001 lot 6603333 mfg 9/2011) was reviewed and the complaint condition was able to be confirmed as the distal tip of the returned instrument is missing a segment of the threaded portion.The 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.Drawings for the sleeve were reviewed during the evaluation.A design change and capa were implemented to address the failure mode of the thread tips breaking.The tip geometry on the inner sleeve was changed to a more constant outer diameter and the material of the outer sleeve changed from radel plastic to anodized titanium.The returned instrument was manufactured in september 2011, after these changes were applied.Review of the dhrs showed there were no issues during the manufacture that would contribute to this 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.

• Brand Name: HOLDING SLEEVE-STANDARD 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: 4892737
• MDR Text Key: 6023568
• Report Number: 1719045-2015-10431
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2015

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: 03.632.001
• Device Lot Number: 6603333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2015
• Initial Date FDA Received: 07/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2011
• 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