MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; PROSTHESIS, RIB REPLACEMENT

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

This report is for one (1) unknown rib hook.Part#, lot# and udi # is not available.Unknown date approximately five (5) years ago.Device remained implanted.Explant date is not applicable.Device is not expected to be returned for manufacturer review/investigation.This report is for one (1) unknown rib hook.Pma/510(k) number is not available.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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

It was reported that the surgeon performed the vertical expandable prosthetic titanium rib with a check wall reconstruction surgery approximately five (5) years ago.Postoperative on (b)(6) 2018, during a chest x-ray it was noticed that the upper cradle/hook joint of a vertical expandable prosthetic titanium rib device was broken.The surgeon did not notice a displaced locking clip and patient had no history of trauma.Patient is asymptomatic, and no additional surgery is scheduled or planned.This report is for one (1) unknown veptr implants: rib hook.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional patient id: (b)(6).Event : corrected x-ray date and implant procedure date in description.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

It was reported that the surgeon performed the vertical expandable prosthetic titanium rib with a check wall reconstruction surgery on an unknown date in 2013.Postoperative on (b)(6) 2018, during a chest x-ray it was noticed that the upper cradle/hook joint of a vertical expandable prosthetic titanium rib device was broken.The surgeon did not notice a displaced locking clip and patient had no history of trauma.Patient is asymptomatic, and no additional surgery is scheduled or planned.This report is for one (1) unknown veptr implants: rib hook.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: based on x-rays provided.The implant was not returned and instead evaluation will be based on the supplied x-rays.Both images were reviewed and the complaint condition of broken postoperative was confirmed as the closing half-ring has broken off from the rest of construct.As the implant was not returned, as received, dimensional, material, or drawing reviews are not applicable.A dhr review for the manufacturing records and the material records could not be performed as the lot number is unknown.No definitive root cause was able to be determined as the circumstances surrounding the event are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed (based on the image) 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.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.

• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7777053
• MDR Text Key: 116912525
• Report Number: 2939274-2018-53289
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2018
• Initial Date FDA Received: 08/13/2018
• Supplement Dates Manufacturer Received: 08/13/2018; 09/18/2018
• Supplement Dates FDA Received: 08/13/2018; 09/19/2018
• Patient Sequence Number: 1
• Patient Age: 16 YR