MAUDE Adverse Event Report: SYNTHES USA 90 DEG TI S-HOOK/RIGHT; PROSTHESIS, RIB REPLACEMENT

Catalog Number 04.601.000

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

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device is expected to be returned for manufacturer review/investigation, but has not been received yet.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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 on an unknown date, a patient underwent a procedure to implant an unknown synthes veptr expandable prosthetic titanium rib.Later, on an unknown date postoperatively, the synthes 90 degree titanium s-hook, right broke.On (b)(6) 2017, the patient was returned to the operating room to revise the veptr construct and remove the complained device.Only a portion of the s-hook was successfully removed, and a portion remained embedded in the patient.The patient was revised to a similar implant.A delay of approximately 45 minutes was reported while the surgeon attempted to remove the broken device; however the procedure was completed successfully.Concomitant devices reported: synthes veptr construct (part #: unknown, lot #: unknown, qty.1).This report is for one (1) 90 deg ti s-hook/right.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product investigation was performed.It was reported that a patient underwent a procedure to implant an unknown synthes veptr expandable prosthetic titanium rib on an unknown date.Later, on an unknown date postoperatively, the synthes 90 degree titanium s-hook, right broke.The patient was returned to the operating room to revise the veptr construct and remove the complained device.Only a portion of the s-hook was successfully removed, and a portion remained embedded in the patient.The patient was revised to a similar implant.A delay of approximately 45 minutes was reported while the surgeon attempted to remove the broken device; however the procedure was completed successfully.The returned device is confirmed to be broken at the bend closest to the pointed tip.The broken fragment was not returned.The device also has some surface scratches consistent with implantation and removal.The dhr for this device is unable to be reviewed as the lot number is unknown.A visual inspection, drawing review, complaint history review and risk assessment review were performed as part of this investigation.The complaint is confirmed.Replication of the complaint condition is not applicable as the device is already broken.The design history was not found to impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for the intended use when employed.Based on the available information there is no way to definitively determine the root cause of the complaint condition.It is unknown how long the device was implanted in the patient prior to breakage.It is possible that the s-hook broke due to being exposed to an unexpected force.The patient was very young and could have contributed to the implant breakage due to non-compliance.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

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: 90 DEG TI S-HOOK/RIGHT
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6282715
• MDR Text Key: 65941138
• Report Number: 2520274-2017-10302
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142587
• 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,Followup,Followup
• Report Date: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 04.601.000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ONE (1) UNKNOWN VEPTR CONSTRUCT
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR