MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI TRANSVERSE RIB HOOK; PROSTHESIS, RIB REPLACEMENT

Catalog Number 04.641.003

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/19/2014

Event Type  malfunction  

Event Description

It was reported that a patient with scoliosis was implanted with veptr ii from t2- l4 on (b)(6) 2014.During the final tightening, the set screw of the transverse rib hook (04.641.003) sheared off and completely broke.Fragments were retrieved easily without additional intervention and rib hook was removed.Another rib hook was readily available and used.A 5 to 10 minutes surgical delay was reported.Procedure was successfully completed without patient harm.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device history report (dhr) record for part # 04.641.003, lot # 5849412, indicates that the reported product was manufactured and released to distribution on 8/15/2008 in accordance with all established requirements with no deviations reported.Dhr records of the finished part # 04.641.003, lot # 5849412 further indicates that product lot underwent all required inspection and was found to meet all established criteria for release to warehouse.The dhr record of the reported product utilized components part # 04.641.003.1 lot # 5688958, 5688959, 5723702, and 5736767: part # 04.641.001.2 lot # 5727872, and 5772676: part # 04.641.001.3 lot # 5727870.The dhr records indicate that the components met all established requirements for use as intended with no nonconformities reported.No relevant material review reports, or nonconformance reports related to this part and lot number.The investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system.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 broke intra-operatively and was not implanted or explanted.The complainant part was lost in transit during the evaluation.Should the device become available, further investigation(s) will be completed and reported at that time.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 TRANSVERSE RIB HOOK
• 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: 4336269
• MDR Text Key: 5142484
• Report Number: 2530088-2014-10429
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK142587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.641.003
• Device Lot Number: 5849412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/15/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 8 YR
• Patient Weight: 32