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

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown veptr implants: distal e./ unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Complainant part is not expected to be returned for manufacturer review / investigation.(b)(4).Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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 reports an event in (b)(6) as follows: it was reported that a surgeon believed it was a fragment of the veptr distal rod might have fractured off after the last distraction procedure and pressure on the construct might have caused the rod to fracture.The fractured piece was tiny (size of a staple or smaller) but did not cause any patient harm so wasn't previously removed until the final surgery.A veptr fracture from 2016.Also reported that pictures were found that was taken at that time.This relates to some of the metal fragments that were removed.Us customer quality will conduct investigation based on the images provided concomitant devices reported: unk - veptr implants: lumbar extension (part # unknown, lot # unknown, quantity unknown), unk - veptr implants: ala hook (part # unknown, lot # unknown, quantity unknown) and unk - veptr implants: lamina hook (part # unknown, lot # unknown, quantity unknown).This complaint involves one (1) unk - veptr implants: distal e.This report is 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.A product investigation was completed: the actual device was not received; however, photographs of the device were provided and the investigation was completed based on those.The photoraphs showed the two (2) portions of the device separated.This is consistent with the reported complaint condition, thus confirming the complaint.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.

• Brand Name: UNK - VEPTR IMPLANTS
• 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: 9139560
• MDR Text Key: 160723970
• Report Number: 2939274-2019-61066
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/03/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/03/2019
• Initial Date FDA Received: 10/01/2019
• Supplement Dates Manufacturer Received: 10/18/2019
• Supplement Dates FDA Received: 10/18/2019
• Patient Sequence Number: 1
• Treatment: UNK - VEPTR IMPLANTS: ALA HOOK; UNK - VEPTR IMPLANTS: LAMINA HOOK; UNK - VEPTR IMPLANTS: LUMBAR EXTENSION; UNK - VEPTR IMPLANTS: ALA HOOK; UNK - VEPTR IMPLANTS: LAMINA HOOK; UNK - VEPTR IMPLANTS: LUMBAR EXTENSION
• Patient Outcome(s): Required Intervention