MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC NAIL EXTRACTOR; ROD, FIXATION, INTRAMEDULLARY

Model Number 03.037.032

Device Problem Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: investigation flow: damage.Visual inspection: the nail extractor (part # 03.037.032/ lot # 9251399) was received at us customer quality (cq).Upon visual inspection, the distal tip was found to be deformed, confirming the complaint condition.No other issues were identified with the returned device.The damaged tip of the device is an end of life indicator for the device.Investigation conclusion: this complaint was confirmed, as the distal tip was deformed.After a visual inspection per guidance provided in windchill document # (b)(4), it is determined that the reusable instrument is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: part: 03.037.032, lot: 9251399, manufacturing site: hägendorf, release to warehouse date: nov 18, 2014.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Device was used for treatment, not diagnosis.

Event Description

It was reported that a proximal femoral nailing system (tfna) nail extractor was found damaged in the sterile processing department (spd).There was no patient involvement.This report is for one (1) nail extractor.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: correction: b4.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: NAIL EXTRACTOR
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10511895
• MDR Text Key: 208148232
• Report Number: 2939274-2020-04066
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982070487
• UDI-Public: (01)10886982070487
• Combination Product (y/n): N
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.037.032
• Device Catalogue Number: 03.037.032
• Device Lot Number: 9251399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Date Manufacturer Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1