MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS G TI RIB SLEEVE-SIZE 12 220MM RADIUS; PROSTHESIS, RIB REPLACEMENT

Catalog Number 497.111

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 12/19/2017

Event Type  Injury  

Manufacturer Narrative

Patient id, date of birth and weight were not provided for reporting.Device malfunctioned intraoperative.Device was not implanted/explanted.(b)(6).(b)(4).The device was received and the product evaluation is in progress.No conclusion can be drawn.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) 2017, patient underwent surgery to remove extension bar due to congenital scoliosis.The fixed area was lib ¿ iliac.During the surgery, the surgeon tried to extend the extension bar several times.However, the extension bar was broken.The extension bar was protruded subcutaneously.Broken fragments were reportedly removed easily.The surgery was completed with no delay.Concomitant devices reported: ti lumbar extension size 12/220 mm radius (part# 497.253, lot# 6905255, quantity 1).Ti distraction lock (part# 497.125, lot# 7430773, quantity 1).This report is for one (1) ti rib sleeve-size 12 220 mm radius.This is report 1 of 1 for (b)(4).

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.

Event Description

When the device was inspected by the manufacturer, it was noted the device was cracked not broken into pieces.

Manufacturer Narrative

A device history record (dhr) review was performed for part number: 497.111, manufacturing lot number: 7060744: supplier lot number: na, manufacturing site: (b)(4), release to warehouse date: 31-oct-2012, supplier: na: no non-conformance reports (ncrs) were generate during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.A product investigation was performed.The returned veptr ti rib sleeve (497.111, 7060744) is part of the vertical expandable prosthetic titanium rib system designed to mechanically stabilize and distract the thorax to correct three-dimensional thoracic deformities.The returned sleeve was received with a portion of its track region cracked and beginning to peel away from the body of the sleeve, which confirmed the complaint condition and made further replication inapplicable.The returned veptr ti rib sleeve (497.111, 7060744) was manufactured on 31oct12 and relevant drawings were reviewed and determined to be suitable for the intended design, application, and dimensional conformity when used and handled as recommended.No mrrs, ncrs, or actions related to the complaint condition were generated during production of the returned part(s).Review of device history record(s) showed that there were no issues during the manufacture of the product(s), which would contribute to the complaint condition.The material, material properties, and hardness of the returned part(s) were determined to be conforming at the time of manufacture and based on review of the associated/available dhr(s) and based on the details of the complaint and investigation of the returned part(s), additional material/hardness testing is not required.During the investigation no unidentified product design issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Dimensional check of relevant features could not be performed due to post-market damage.Based on the damage noticed on the returned sleeve it appears as though it was extended as far as possible, which could have led to it experiencing an excessive load, which in turn caused it to crack.Based on the available information it is not possible to determine a definitive root cause for the complaint condition, however it was stated in the event description that the surgeon tried to extend the extension bar several times, and if it was fully extended, the resulting forces could have contributed to the 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.

• Brand Name: TI RIB SLEEVE-SIZE 12 220MM RADIUS
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS G; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7204056
• MDR Text Key: 97720154
• Report Number: 8030965-2018-50452
• Device Sequence Number: 1
• Product Code: MDI
• UDI-Device Identifier: 07611819747173
• UDI-Public: (01)07611819747173(10)7060744
• Combination Product (y/n): N
• PMA/PMN Number: K142587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2017

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 497.111
• Device Lot Number: 7060744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Initial Date Manufacturer Received: 12/19/2017
• Initial Date FDA Received: 01/18/2018
• Supplement Dates Manufacturer Received: 01/23/2018; 03/16/2018
• Supplement Dates FDA Received: 02/13/2018; 03/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention