MAUDE Adverse Event Report: SYNTHES BRANDYWINE IMPACTOR SMALL/STRAIGHT

Catalog Number 396.398

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: there was no known reported patient involvement associated with the complained event.Date of event is unknown.Device is an instrument and is not implanted/explanted.A device history record review was performed for part #396.398, lot #3994794: release to warehouse date: 26-aug-1999: manufactured by: synthes (b)(4): no non-conformance reports (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.Subject device has been received and is currently in the evaluation process.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

It was reported that the handle of an impactor was found to be broken in sterile processing.The handle was found cracked and fragments were generated.There was no patient involvement.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device.The returned device was examined and the complaint condition of broken was able to be confirmed as the phenolic handle was found to be broken into three pieces at the distal cross-pin.No definitive root cause was able to be determined however the device handle was composed of phenolic le grade which is susceptible to becoming brittle after repeated thermal cycle such as that which would occur during the sterilization cycle.As the device is 17+ years old (mfg aug-1999), instrument age likely contributed to the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint is confirmed.The impactor small/straight ((b)(4)) is one of four impactors in the synmesh system (technique guide).Once the implant has been assembled, the corpectomy performed and the segment distracted, the implant can be inserted by using the appropriate impactor.Relevant drawings for the returned instrument were reviewed: top-level and handle.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: IMPACTOR SMALL/STRAIGHT
• Type of Device: IMPACTOR
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6166117
• MDR Text Key: 62381121
• Report Number: 2530088-2016-10344
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10705034777535
• UDI-Public: (01)10705034777535(10)3994794
• 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
• Report Date: 11/21/2016

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: 396.398
• Device Lot Number: 3994794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/21/2016
• Initial Date FDA Received: 12/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/1999
• 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