MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI EXTENDED CRADLE END HALF; PROSTHESIS, RIB REPLACEMENT

Catalog Number 497.129

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Patient id/initials, age/date of birth and weight are unknown complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2015 a new veptr was stabilized, ranging from the left fifth lib to the ileum.On (b)(6) 2015 the surgery for adjusting veptr size was performed.On (b)(6) 2016 (b)(6) infection was noticed again.On (b)(6) 2016 the veptr, stabilized between the left fifth lib and the ileum, was removed.The patient has been well.The veptr treatment has been continued.This is report 4 of 9 for (b)(4).

Manufacturer Narrative

A device history record review (dhr) was performed for the subject device lot number 6987526.Manufacturing location: (b)(4).Date of manufacture: 23-jul-2012.Dhr review of the raw material part# 24023 lot# 6659987 found a nonconforming report due over size width of the samples inspected.The material was dispositioned as ¿use as is¿ due to the excess material being remove during the machining operation.This nonconformance is not related to the complaint condition.Also, part# 497.129 lot# 6987526 was part of stock hold which was initiated for lots that had been packaged with unapproved packaging inserts.The lot was reworked and it was found that the lot did not contain the unapproved inserts.The parts were placed back in inventory without further action.Dhr review found no relevant issues that would result in this product complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Investigation summary: products were not returned.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.There is no allegation of device defect, deficiency or surgical technique error associated with this complaint.As there is no device malfunction alleged and no associated surgical technique error.Complained issue could not be confirmed.No pictures/ no x-rays were provided which would provide additional evidence.Complaint unconfirmed.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.

• Brand Name: TI EXTENDED CRADLE END HALF
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6617361
• MDR Text Key: 76837001
• Report Number: 2530088-2017-10184
• Device Sequence Number: 1
• Product Code: MDI
• UDI-Device Identifier: 07611819747326
• UDI-Public: (01)07611819747326(10)6987526
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2017

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 497.129
• Device Lot Number: 6987526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2017
• Initial Date FDA Received: 06/07/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/20/2017; 06/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention