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

Catalog Number	03.616.042
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.The subject device has been received and is currently undergoing investigation.A device history record review was performed for the subject device lot.Manufacturer: synthes (b)(4).Date of manufacture: may 5, 2012.The review revealed that one nonconformance report (ncr) was generated because the treated ring would not go more than 1.5 turns, most are 2 turns.Twenty-five (25) units were inspected and 9 parts were rejected and reworked.The review 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 or Problem Description
It was report that during an initial posterior lumbar inter-body fusion (plif) procedure at disc levels l4-l5 and l5-s1 on (b)(6) 2017 involving the implantation of two (2) unknown opal spacers, eight (8) unknown screws and two (2) unknown rods, several instrument malfunctions occurred.During screw insertion at unknown disc levels, two (2) locking holding sleeves were reported to have stripped threads.While surgeon was attempting spacer insertion the prong on the opal implant holder was discovered to have bent.During another screw insertion attempt at an unknown disc level, the star-drive shaft instrument was noted to be stripped and not working correctly.Also, the ratchet t-handle instrument would not spin, causing instrument to not tighten during implant insertion.Back up instruments were available in the operating room.No fragments were generated during the reported instrument events.A five (5) minute surgical delay was reported.The surgery was completed successfully and patient is reported in stable condition.Concomitant devices: unknown screws (item # unknown, lot # unknown, quantity 8).Unknown opal spacer (item # unknown, lot # unknown, quantity 2).Unknown rods (item # unknown, lot # unknown, quantity 2).This report is 1 of 2 for (b)(4).
Additional Manufacturer Narrative
A product development investigation was performed.The holding sleeves with part 03.616.042, lot 6826713 (mfg 05-may-2012) and 6778558 (mfg 20-jan-2012) were received.A visual inspection, functional test, device history records review, and drawing review were performed as part of this investigation.This complaint is confirmed.The tips of the 03.616.042 holding sleeves were both damaged.The first thread of lot 6826713 had pulled completely away from the remaining threads but was not broken while lot 6778558 was just starting to pull away but was still connected on both ends.A functional test is not required for the bent/stripped devices as the complaint was able to be visually confirmed.A definitive root cause was unable to be determined.The failure modes are consistent with the application of an off-axis load while engaging a screw.Relevant drawing was reviewed.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.During the investigation no product design issues or discrepancies were observed that may have contributed 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.

• Brand Name: LOCKING HOLDING SLEEVE- STANDARD FOR MATRIX
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6515055
• Report Number: 1719045-2017-10336
• Device Sequence Number: 1331614
• Product Code: LXH
• UDI-Device Identifier: 10705034716336
• UDI-Public: (01)10705034716336(10)6826713
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03.616.042
• Device Lot Number: 6826713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/31/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2017
• Supplement Report FDA Received Date: 05/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN OPAL SPACER, QTY. 2; UNKNOWN RODS, QTY. 2; UNKNOWN SCREWS, QTY. 8
• Patient Age: 58 YR
• Patient Weight: 109