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

Catalog Number 04.641.001

Device Problem Break (1069)

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

Event Date 09/28/2015

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient initials are (b)(6).Patient weight was not provided by reporter.Additional event and patient information was requested but was not provided by the reporter.The complaint device is expected to be returned to synthes for evaluation.Reporter facility phone number is (b)(6).Without a lot number the device history records review could not be completed.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

Device report from synthes europe reported an event (b)(6) as follows: it was reported that during placement of the rib hook, the hook broke.There was another device available to complete the procedure.There was no harm to the patient or surgical delay.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.The lot number of the subject device was identified upon receipt.Other number¿udi.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The subject device has been received and is currently in the evaluation process.Manufacturing location of the device was identified and corrected.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device broke intra-operatively and was not implanted or explanted.Product investigation summary: one (1) titanium rib hook (part 04.641.001 / lot 7506200) was returned with a complaint stating that the implant broke during placement.Upon inspection of the returned part, the complaint was able to be confirmed as the square tab of the hook body was completely detached.Although the definitive root cause cannot be determined, it is likely that excessive force and angulation while inserting the rib hook cap into the slot of the rib hook and over the rib contributed to the complaint condition.The vertical expandable prosthetic titanium rib (veptr) ii system is designed to mechanically stabilize and distract the thorax to correct three-dimensional thoracic deformities and provide improvement in volume for respiration and lung growth in infantile and juvenile patients diagnosed with and/or at risk of developing thoracic insufficiency syndrome.Within the system, the rib hook attaches to the hook cap and proximal extension to support the superior rib, or the distal extension to support the inferior rib.The hook cap attaches to the rib hook to encircle the superior or inferior rib and the distraction lock connects the components.The relevant product drawings were reviewed during the investigation and the design history was found to not impact the complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition and changes in subsequent revisions were not relevant to the complaint condition.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.No non-conformance reports were generated during production.The design is adequate for its intended use when used and maintained as recommended, it did not contribute to the complaint condition.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 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: 5150396
• MDR Text Key: 28305504
• Report Number: 2520274-2015-16652
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Followup,Followup
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.641.001
• Device Lot Number: 7506200
• Other Device ID Number: (01)07611819352766(10)7506200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 10 YR