MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI PROXIMAL EXTENSION SIZE 10/220MM RADIUS; PROSTHESIS, RIB REPLACEMENT

Catalog Number 04.641.100

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2014

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that during the haste profile operation using the adequate tool the piece broke.No extend time was observed.The part was not implemented in our patient.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history review was conducted.The report indicates that the product was manufactured at the brandywine manufacturing facility on 03/29/2012 under work order (b)(4).Dhr records indicate that the product lot was manufactured in accordance with all established requirements with no nonconformities reported.Dhr records for part # 04.641.100, lot # 6904505 further indicates that the product lot underwent all specified inspection requirements with no product nonconformities reported.Dhr records for p/n 04.641.100, lot # 6904505 indicate that the product lot was produced from raw material tialnbfi120.00x18.00, p/n 24019, lot # 6655151 in accordance with established specifications.Dhr records for raw material tialnbfi120.00x18.00, p/n 24019, lot # 6655151 indicate that the raw material was received at the (b)(4) facility on 04/21/2011 and released to inventory on 06/23/2011.Dhr records for the raw material lot further indicate that the raw material underwent all specified inspection and testing requirements and was found to meet all established criteria for acceptance and use as intended.There is no objective evidence within the dhr for the reported product indicating that its manufacturing processes contributed to the reported complaint category.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 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

(b)(4): device was not implanted/explanted.A manufacturing evaluation was completed: part 04.641.093 ti proximal extension, lot 6904505 has been received with post manufacturing damage consisting of scratches, nicks, discoloration and tool marks on several surface areas.Part was also received broken into two pieces.The complaint condition pertaining to the broken proximal extension was confirmed due to the observed post manufacturing damage.However, all pertaining features couldn't be properly evaluated due to as received post manufacturing damage of the part (broken in two pieces).All other relevant features to the part met specification; therefore, the complaint is unconfirmed from a manufacturing perspective.Root cause cannot be determined due to the damage of the part.No indication for material or design related issue.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TI PROXIMAL EXTENSION SIZE 10/220MM RADIUS
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4361616
• MDR Text Key: 5264070
• Report Number: 2530088-2014-10447
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: PK142587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/10/2014

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: 04.641.100
• Device Lot Number: 6904505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/30/2015
• Initial Date FDA Received: 12/24/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/19/2015; 07/27/2015; 07/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1