MAUDE Adverse Event Report: SYNTHES HAGENDORF PHILOS AIM-DEVICE W/O NOSE; GUIDE

Catalog Number 03.122.057

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 09/14/2017

Event Type  Injury  

Manufacturer Narrative

Patient age, dob & weight not provided for reporting.(b)(4).Device is an instrument and is not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was not returned and no lot number was provided.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 on an event in (b)(6) as follows: it was reported that the reported devices were used in the surgery on (b)(6) 2017.After the plate was fixed by screws, the surgeon forgot to remove the guiding block and completed the surgery.This was found by the post-operative x-ray images, and the removal surgery was performed under full anesthesia on the same day.The surgeon commented that this happened due to a human error.This complaint involves 1 part.Concomitant device: 1x 441.901s / lot unk (philos 3.5 3ho ti).This report is 1 of 1 for (b)(4).

• Brand Name: PHILOS AIM-DEVICE W/O NOSE
• Type of Device: GUIDE
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6915977
• MDR Text Key: 88237028
• Report Number: 3003875359-2017-10487
• Device Sequence Number: 1
• Product Code: FZX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.122.057
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR