MAUDE Adverse Event Report: SYNTHES BRANDYWINE 90 DEG TI S-HOOK/LEFT; PROSTHESIS, RIB REPLACEMENT

Catalog Number 04.601.001

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Dob, weight not provided by reporter.It is unknown when the breakage occured.(b)(4): the manufacturing location for part # 04.601.001 / lot # 6887031 is brandywine.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

Report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the reported s-hook implant breakage occurred and the re-operation was performed on (b)(6) 2015 as consequences below; unknown date: the patient was originally being treated for thoracic insufficiency syndrome with veptr.On (b)(6) 2015: the implanted veptr was replaced with veptr ii in region of lib-iliac while the reported s-hook (04.601.001) was continuously applied to the patient.The transverse cradle was added for lib to strengthen stability.After implantation of veptr ii: the breakage occurred and the patient visited the reporting hospital.On (b)(6) 2015: all s-hooks 5 mm including the reported one were removed and replaced with veptr ii 6mm.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Additional narrative: subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records was conducted.The report indicates that the: manufacturing date: 22feb2012, part 04.601.001, lot # 6887031 did not contain any ncrs or any anomalies.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 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

A manufacturing investigation was performed for the subject device (part number 04.601.001, 90 deg ti s-hook/left, lot number 6887031).The subject device was received in a broken condition with scratches and heavy wear and tear signs on the surface.On some surface areas, the anodized color is partially disappeared, especially where the surface is damaged.The laser etching is readable.The manufacturing review shows that the production procedure of the subject device was according to the specifications and there were no issues that would contribute to this complaint condition.The complaint relevant dimensions were checked as far as possible and were found to be within specifications.No manufacturing related issues were identified and/or confirmed.No product fault could be detected.Based on the received information the exact root cause of this complaint could not be determined because no detailed information about the event is available.It is possible that the failure of the hook was due to a mechanical overload situation.The postoperative activities of the patient may also have played a certain role of this occurrence.The complaint relevant dimensions were checked (as far as possible) and found to be within specifications.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 90 DEG TI S-HOOK/LEFT
• 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: 5025968
• MDR Text Key: 23904450
• Report Number: 2530088-2015-10566
• 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: Physician
• Report Date: 08/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.601.001
• Device Lot Number: 6887031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR