MAUDE Adverse Event Report: SYNTHES BRANDYWINE ACF TRIAL SPACER/LORDOTIC 9MM; TEMPLATE

Catalog Number 396.419

Device Problems Detachment Of Device Component (1104); Material Fragmentation (1261); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No reported patient or surgical involvement.The exact date of device breakage is unknown; however, the issue was discovered during an equipment inspection on (b)(6) 2016.Device is an instrument and is not implanted or explanted.Product investigation summary: the returned trial spacers were examined and the complaint conditions were able to be confirmed in each instance as the phenolic handles were found to be loose and able to spin on the trial shaft.Additionally, the cross-pins on both handles were found to be missing.The handle material is phenolic le grade, which is susceptible to becoming brittle after being subjected to the years of thermal cycling that routinely occurs during sterilization cycles.This expansion/contraction and material breakdown can result in a loose assembly resulting in the observed complaint condition.The devices are 15+ years old; therefore, the device age is likely a contributing factor.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, functional check, and drawing review were performed as part of this investigation.The 9mm/10mm acf trial spacers are utilized for spacer trialing in the anterior cervical fusion (acf) system.Following distraction, discectomy, and endplate preparation, it is necessary to determine which implant is appropriate for the segment.The acf system offers parallel, lordotic, and convex spacers in sizes ranging from 5mm-12mm.Both fixed and detachable trials are available in the system.The relevant drawings for the returned instruments were reviewed: top-level and handle.The design, materials, and finishing processes were found to be appropriate for the intended use of these devices.No definitive root cause was identified.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Device history record review: manufacturing date: april 25, 2001 - supplier- (b)(4).No non-conformance reports 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.A material record report was implemented for a ¿bad etch¿ on one side of spacer.The pieces were reworked and passed final inspection.Device 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

It was originally reported that two (2) anterior cervical fusion (acf) trial spacers (9mm and 10mm) were found to be broken during a field equipment inspection conducted on june 15, 2016.At the time, the reporter indicated that the actual malfunction referred to loose and spinning instruments.There was no known patient or procedural involvement.Upon inspection of the returned devices on july 11, 2016, it was noted that the cross-pins from the handles were missing.These pins are approximately 10mm long x 0.5mm diameter and "could" potentially fall out during a procedure, especially if the handle has been subjected to repeated sterilization cycles.Based upon this updated information, the complaint was re-evaluated and determined to now represent a reportable incident.This report is 1 of 2 for (b)(4).

• Brand Name: ACF TRIAL SPACER/LORDOTIC 9MM
• Type of Device: TEMPLATE
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5808942
• MDR Text Key: 50914685
• Report Number: 2530088-2016-10192
• Device Sequence Number: 1
• Product Code: HWT
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 396.419
• Device Lot Number: 4246194
• Other Device ID Number: (01)10705034777696(10)4246194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2001
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1