MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH VERTEBRAL SPACER-TR 10MMX27MM 13MM HEIGHT; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number 889.837S

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided for reporting.Date of event is unknown.Device malfunctioned intraoperative.Device was not implanted/explanted.Device is expected to be returned for manufacturer review/investigation but has not been received yet.Reporter is synthes sales representative.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review has been requested.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 europe reports an event in (b)(6) as follows: it was reported that on an unknown date during the surgery, while the surgeon was using the mallet to insert the travios cage, the cage broke.This report is for one (1) vertebral spacer-tr 10mmx27mm 13mm height.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Part: 889.837s; lot: aa3636; manufacturing site: mezzovico; supplier: ortek ag; release to warehouse date: july 24, 2017; expiry date: july 01, 2027.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Investigation site: cq zuchwil; selected flow 5: broken.Visual investigation: the received travios plastic cage (peek: organic thermoplastic polymer) implant is broken into five fragments of varied sizes, therefore the complaint is confirmed.The two positioning pins are still present in the fragments.Dimensional inspection: because of the existing damage, the complaint relevant dimensions cannot be checked for dimensional accuracy of the valid manufacturing specifications.Document/specification review: the cause of the malfunction is a post-manufacture breakage / damage of the device due to mechanical overload, therefore no drawing / specification check is required.Material review: raw material was received from invibio biomaterial solutions, on november 11, 2016.The certificate of analysis conforms to the requirements of the purchase order.Investigation conclusion: based on the condition of the received product and the available poor information, a manufacturing conclusion cannot be presented.The device history review shows that the correct raw material was used, and the implant met fully to our specifications at the time of manufacturing.There were no issues during manufacturing that would contribute to this complaint condition.The most probable root cause of breakage was mechanical overload of the implant while surgery.No manufacturing related issue was identified and/or confirmed.Based on the investigation findings, it has been determined that no corrective and/or preventative action is appropriate.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: VERTEBRAL SPACER-TR 10MMX27MM 13MM HEIGHT
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7776482
• MDR Text Key: 117003143
• Report Number: 8030965-2018-55652
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 07611819886162
• UDI-Public: (01)07611819886162
• Combination Product (y/n): N
• PMA/PMN Number: K011037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/25/2018

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: 889.837S
• Device Lot Number: AA3636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Initial Date Manufacturer Received: 07/25/2018
• Initial Date FDA Received: 08/13/2018
• Supplement Dates Manufacturer Received: 08/29/2018
• Supplement Dates FDA Received: 09/17/2018
• Patient Sequence Number: 1