MAUDE Adverse Event Report: SYNTHES USA; PROSTHESIS, RIB REPLACEMENT

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.It is unknown when the breakage occured.This report is for one unknown veptr/unknown lot number.Subject device has not been received.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 received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The reported s-hook implant breakage occurred and the re-operation was performed on (b)(6) 2015 as consequences below; unknown date: the patient was originally being treated for thoracic insufficiency syndrome with veptr.On (b)(6) 2015: the implanted veptr was replaced with veptr ii in region of lib-iliac while the reported s-hook (04.601.001) was continuously applied to the patient.The transverse cradle was added for lib to strengthen stability.After implantation of veptr ii: the breakage occurred and the patient visited the reporting hospital.On (b)(6) 2015: all s-hooks 5 mm including the reported one were removed and replaced with veptr ii 6mm.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

A dhr review was performed on the concomitant components of the veptr ii device: part#04.641.101 lot#7642432.Release to warehouse date: june 2, 2014.Supplier- (b)(4).No ncrs were generated during production.Part#04.641.121 lot#7642436.Release to warehouse date: april 24, 2014.Supplier- (b)(4).No ncrs were generated during production.Part#04.641.025 lot#7809987.Release to warehouse date: september 25, 2014.Supplier- (b)(4).One ncr was noted, however ncr is not relevant to complaint condition "s-hook implant breakage occurred" because ncr relates to a detent width on conical set screw with no bearing on s-hook strength.Part#04.641.003 lot#7786052 release to warehouse date: september 3, 2014 supplier- (b)(4).Two ncrs were noted however are not relevant to complaint condition "s-hook implant breakage occurred" because ncrs relate to oversized diameter and undersized length features on transverse rib hook body component with no bearing on s-hook strength.Part#04.641.004 lot#7775155.Release to warehouse date: september 15, 2014.Supplier- (b)(4).No ncrs were generated during production.Part#498.162 lot#7564965.Release to warehouse date: march 11, 2014.Supplier- (b)(4).No ncrs were generated during production.Part#497.125 lot# 7742870.Release to warehouse date: july 28, 2014.Supplier- (b)(4).No 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.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

The reported unknown veptr ii system includes the following concomitant parts: part 04.641.101 / lot 7642432: ti proximal extension size 11/220mm radius ¿ mdi ¿ brandywine ¿ (b)(4), part 04.641.121 / lot 7642436: ti distal extension size 11/220mm radius ¿ mdi ¿ (b)(4), part 04.641.025 / lot 7809987: 6.0mm ti transverse bar 15mm ¿ mdi ¿ (b)(4), part 04.641.003 / lot 7786052: ti transverse rib hook ¿ mdi ¿ (b)(4), part 04.641.004 / lot 7775155: ti rib hook cap/standard ¿ mdi ¿ (b)(4), part 498.162 / lot 7564965: ti parallel connector 5.0mm/6.0mm ¿ kwp, mnh, and mni ¿ (b)(4), part 497.125 / lot 7742870 (x2): ti distraction lock ¿ mdi ¿ (b)(4).Device 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.

• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5025987
• MDR Text Key: 23905067
• Report Number: 2520274-2015-15439
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 08/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• 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: 12 YR