MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM CANNULATED SCREW LONG THREAD/40MM; SCREW, FIXATION, BONE

Model Number 207.740

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 (b)(6) 2018, the customer received an empty package of a cannulated screw long thread.It is unknown if when was the issue discovered.There was no patient and procedure involvement.This report is for one (1) 4.0mm cannulated screw long thread/40mm.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The initial complaint was reviewed and found not reportable.Engineering indicates that an empty fedex pouch and not an empty synthes package was returned as the device in question.Since this is an empty fedex pouch and not an empty synthes package, this would actually be a distribution issue/complaint and not a product complaint.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: 4.0MM CANNULATED SCREW LONG THREAD/40MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8026319
• MDR Text Key: 125786173
• Report Number: 2939274-2018-54724
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886982148506
• UDI-Public: (01)10886982148506
• Combination Product (y/n): N
• PMA/PMN Number: K963192
• 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: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 207.740
• Device Catalogue Number: 207.740
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2018
• Patient Sequence Number: 1