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

Catalog Number 04.601.001

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient information not available for reporting.Date of event: unknown.(b)(4) lot number unknown.Original implant date unknown.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.(b)(6).(b)(4).Subject device has not been received.Without a lot number, the device history record review and 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 on an event in (b)(6) as follows: it was reported that the s-hook was broken postoperatively.The hospital reported that the s-hook which was implanted to the right ilium was broken in the patients body (the exact date when the s-hook was broken was unknown).As the x-ray photos was reviewed at the hospital, and it was revealed that the patient had one each of veptr ii for both right and left side, but the only right side was broken.The revision surgery was scheduled on (b)(6) 2016.The patient was only on daily activities.The revision surgery was completed successfully.This complaint involves 1 part.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Concomitant devices include one each of the following: part number 498.162, lot number 6988592 (parallel connector f/uss smstature/paediatric rods); part number 497.125, lot number 9940781 (closure f/extension bar); part number 04.641.057, lot number 9819388 (proximal extension, radius 500mm, size 7); part number 04.641.077, lot number 9833264 (distal extension, radius 500mm, size 7).The date of implant (therapy date) is unknown.A device history record review was performed for the device lot number 693737.Manufacturer: synthes (b)(4).Date of manufacture: jul 1, 2011.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 complaint device.The complaint device has been received and is currently in the investigation process.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Additional information was received on aug 10, 2016.The surgeon clarified that there were two hooks on the rib; however, there was only one 5mm s-hook on ilium.The s-hook had broken post-operatively.

Manufacturer Narrative

A product investigation was completed: a visual inspection, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint is confirmed.The returned concomitant implants were examined and no defects or deficiencies were identified which may have contributed to the complaint condition.Per the technique guide, the 90 degree titanium s-hook left (04.601.001) is a component of the veptr ii system instrument and implant set (01.641.001).The veptr ii (vertical expandable prosthetic titanium rib) is utilized 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 or at risk of developing thoracic insufficiency syndrome.The s-hook is specifically utilized with the distal extension and connector to attach the construct to the ilium and are available in either left or right contours and in either 45 or 90 degree bends.The returned s-hook was examined and the complaint condition was able to be confirmed as the implant was returned broken into two segments; all fragments were returned.Relevant drawings for the returned device were reviewed; both current revision and from the time of manufacture.The design, materials and finishing processes were found to be appropriate for the intended use of this device.A device history review was performed for the returned implant¿s lot number and no material review reports, non-conformance reports or complaint-related issues were identified with the lot numbers which may have contributed to the complaint condition.Two rework/sorts were completed on the raw material to verify/ensure the correct alloy was utilized/marked in order to prevent material mix-up.No definitive root cause was able to be determined with the provided information.During the investigation no product design issues or discrepancies were observed that may 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.

Event Description

Concomitant devices: parallel connector (part 498.162, lot 6988592, quantity 1); closure extension bar (part 497.125, lot 9940781, quantity 1); proximal extension (part 04.641.057, lot 9819388, quantity 1); distal extension (part 04.641.077, lot 9833264, quantity 1).

• Brand Name: 90 DEG TI S-HOOK/LEFT
• Type of Device: PROSTHESIS, RIB REPLACEMEN
• 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5809371
• MDR Text Key: 50016235
• Report Number: 2520274-2016-13542
• Device Sequence Number: 1
• Product Code: MDI
• 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: 07/06/2016

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: 04.601.001
• Device Lot Number: 6693737
• Other Device ID Number: (01)10705034734248(10)6693737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2016
• Initial Date FDA Received: 07/20/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/12/2016; 09/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention