MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 14MM; SCREW, FIXATION, BONE

Model Number 204.814

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history record has been requested.Investigation summary 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.A review of the device history record.Device history lot.Part number: 204.814 synthes lot number: 43p7003.Manufactured by jabil inc-monument.A dhr file from the time of manufacture could not be reviewed because it is not been scanned into tungsten yet.Jde confirmed that the lot was released for sale in apr 2020.A search in mdd nonconformance module confirmed that no non-conformances occurred during manufacture.Device history batch null, device history review a search in mdd nonconformance module confirmed that no non-conformances occurred during manufacture.

Event Description

It was reported that on an unknown date, the facility took a picture of the implants shipped to show the order confirmation, however, the implants were not inside the bag and the bag was not damaged.The facility placed a standard order and six (6) items were shipped with a quantity of one (1) on each item and none of those items were in the bag.There was no patient nor procedure involvement.This complaint involves three (3) devices.This report is for one (1) 3.5mm cortex screw self-tapping 14mm this report is 1 of 3 for (b)(4).

• Brand Name: 3.5MM CORTEX SCREW SELF-TAPPING 14MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10018808
• MDR Text Key: 190117811
• Report Number: 2939274-2020-02192
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886982146250
• UDI-Public: (01)10886982146250
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 204.814
• Device Catalogue Number: 204.814
• Device Lot Number: 43P7003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1