MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC INSERTION HANDLE F/HINDFOOT ARTHRODESIS NAIL-EX; GUIDE

Catalog Number	03.008.007
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is synthes sales consultant.A review of the device history records has been requested.The device was received, the investigation is in progress, 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 or Problem Description
It was reported that during a routine inspection of the devices on an unknown date, it was noted that the insertion handle for hindfoot arthodesis nail and the nail did not seem tight when put together.It is not known if the connecting screw or the prongs of the insertion handle are damaged, as it was the insertion handle that seemed to have a little play.There was no patient or surgical procedure involvement.Concomitant devices: cannulated screw (part unknown, lot unknown, quantity unknown), hindfoot arthodesis nail (part unknown, lot unknown, quantity unknown).This report is for one (1) insertion handle for hindfoot arthrodesis nail.This is report 1 of 2 for (b)(4).
Event or Problem Description
This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Part 03.008.007, lot 3535223: manufacturing site: (b)(4).Release to warehouse date: november 08, 2010.The device history record shows this lot of devices was processed through the normal manufacturing and inspection operations.No non-conformance reports (ncrs) that would contribute to this complained event were noted.A product investigation was completed: visual and functional inspection performed at customer quality (cq) identified worn and slightly deformed tab edges under 5x magnification on the returned hindfoot insertion handle.No further visual defects were identified.With the slight deformation observed the overall complaint condition was confirmed.However, both complaint condition replication and functional inspection involving assembly of inserter with the nail could not be performed as the mating nail was not returned.The device condition agrees with the reported complaint description and therefore the complaint condition was confirmed.The relevant drawings were reviewed, and no design issues were noted.Dimensional inspection performed on relevant features measured within the specification.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to complaint condition.A definitive root cause could not be determined based on the provided information.The complaint condition was confirmed.However, during the investigation, no product design issues or relevant manufacturing discrepancies were observed 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.

• Brand Name: INSERTION HANDLE F/HINDFOOT ARTHRODESIS NAIL-EX
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8009080
• Report Number: 2939274-2018-54634
• Device Sequence Number: 11151110
• Product Code: FZX
• UDI-Device Identifier: 10886982066855
• UDI-Public: (01)10886982066855
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03.008.007
• Device Lot Number: 3535223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 10/26/2018
• Supplement Report FDA Received Date: 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1