MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 90 DEG TI S-HOOK/RIGHT; PROSTHESIS, RIB REPLACEMENT

Model Number 04.601.000

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: (b)(6).Patient weight not available for reporting.Date of device breakage is not known.(b)(4), lot unknown.Date of implant is not known.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.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 patient was implanted with the veptr rib expansion construct on unknown date.Patient was returned to surgery on (b)(6) 2017 due to a broken 90 degree titanium s-hook/right.The s-hook was replaced, surgery was completed successfully.(b)(4).

Manufacturer Narrative

The subject device has been received by the manufacturer and is undergoing investigation.The results of the investigation are pending completion and will be submitted in a supplemental 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.

Manufacturer Narrative

Part 04.601.000, lot h170137: release to warehouse date: september 02, 2016.Manufacturing site: (b)(4).No non-conformance reports were generated during production.Review of the device history record (dhr) showed that there were no issues during the manufacture of this product, and any sub-components, that would contribute to this complaint condition.A product investigation was completed: the returned s-hook was confirmed to be broken.The broken fragments were returned.The s-hook was also found to be bent and has nicks and gouges across the balance of the device.Replication of the complaint condition is not applicable as the device is already broken.The diameter of the broken fragment of the hook measured and were within the specification.Based on review of the dhr records there is no indication that any material issues contributed to the complaint condition.There were no issues during the manufacture of this product that would contribute to this complaint condition.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

It was noted the patient was stable following surgery.Initially it was reported the pelvic hook fractured into pieces that were difficult to remove.During the investigation it was noted it was also found to be bent and has nicks and gouges across the balance of the device.

• Brand Name: 90 DEG TI S-HOOK/RIGHT
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7148579
• MDR Text Key: 95846096
• Report Number: 2939274-2017-50453
• Device Sequence Number: 1
• Product Code: MDI
• UDI-Device Identifier: 10705034734231
• UDI-Public: (01)10705034734231(10)LOTUNKNOWN
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/29/2017

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 Model Number: 04.601.000
• Device Catalogue Number: 04.601.000
• Device Lot Number: H170137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/27/2017
• Supplement Dates Manufacturer Received: 12/29/2017; 01/25/2018
• Supplement Dates FDA Received: 01/23/2018; 01/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2016
• 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