MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM KIRSCHNER WIRE THREADED SPADE POINT TIP 280MM; NAIL, FIXATION, BONE

Model Number 292.699

Device Problem Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional device product code: hwc; hrs.The device has been 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 Description

It was reported that on an unknown date, a kirschner wire threaded spade point was received bent for restock.It was ordered restock from a case the day before and received the item the next day.When took it out to restock the set it was noticed as bent.There was no patient involvement.This report is for one (1) 2.0 mm kirschner wire threaded spade point this is report 1 of 1 for complaint (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.H10 additional narrative: h3, h6: background.It was reported that on an unknown date, a kirschner wire threaded spade point was received bent for restock from the libertas program.It was ordered restock from a case the day before and received the item the next day.When took it out to restock the set it as noticed bent.There was no patient involvement.This complaint involves one (1) device.Flow : damage.Visual inspection: upon inspection, it was noticed that the device was bent.Hence, the complaint can be confirmed.Dimensional inspection: it was not performed due to post manufacturing deformation.Document/ specification review: 292_699 rev a.Conclusion: the complaint is confirmed for the bent.The exact cause of the damage is unknown, but it is likely due to wear from repeated use over the lifetime of the multiple use devices.During the investigation no unidentified product design/manufacturing issues or 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.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.H3, h4, h6: a review of the device history record.Device history lot: part: 292.699; lot: 8780921; manufacturing site: balsthal; release to warehouse date: 23.Dec.2013.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.0MM KIRSCHNER WIRE THREADED SPADE POINT TIP 280MM
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9084254
• MDR Text Key: 159181383
• Report Number: 2939274-2019-60683
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 10886982180834
• UDI-Public: (01)10886982180834
• Combination Product (y/n): N
• PMA/PMN Number: K962047
• 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: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 292.699
• Device Catalogue Number: 292.699
• Device Lot Number: 8780921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Date Manufacturer Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1