MAUDE Adverse Event Report: SYNTHES HAGENDORF SYNFRAME FLEX ARM BRIDGE; MISC ORTHO SURGICAL INSTR

Catalog Number	03.612.012
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: patient information is unknown.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).Manufacturing location: (b)(4).Manufacturing date: september 05, 2012.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 the product that would contribute to this complaint condition.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.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 or Problem Description
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during a primary spine surgery on (b)(6) 2017, it was not possible to insert the flex-arm inside the synframe guiding tube.Additionally it was not possible to lock the flex-arm.The surgeon had to change his procedure and the patient was not implanted with a cage.The patient may have to come back for a new intervention.The surgery was prolonged about fifteen (15) minutes but there was no patient harm.No information available about patient outcome and condition.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
The initial complaint was reviewed and found not reportable.It was determined that there is no allegation against this device and it will be reported as concomitant.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.
Additional Manufacturer Narrative
The initial complaint was reviewed and found not reportable.It was determined that there is no allegation against this device and it will not be reported as concomitant.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: SYNFRAME FLEX ARM BRIDGE
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6590370
• Report Number: 3003875359-2017-10251
• Device Sequence Number: 10949361
• Product Code: LXH
• UDI-Device Identifier: 07611819813731
• UDI-Public: (01)07611819813731(10)8058562
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.612.012
• Device Lot Number: 8058562
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/27/2017
• Supplement Date Received by Manufacturer: 07/05/2017; 07/26/2017
• Initial Report FDA Received Date: 05/25/2017
• Supplement Report FDA Received Date: 07/05/2017; 07/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention