MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 24MM; SCREW, FIXATION, BONE

Model Number 204.824

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Hrs, jds.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 #: 204.824.Synthes lot number: 46p1090.Supplier lot number: 46p1090.Manufacturing site: jabil-monument.Release to warehouse date: unk.Device history batch null, device history review a dhr file cannot not be reviewed as it has not yet been scanned into tungsten as of (b)(6) 2019.Jde confirmed the lot was released for sale (b)(6) 2020 and an etq mdd nonconformance module search confirmed that no ncrs were generated during production.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, 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 report is 4 of 4 for (b)(4).

• Brand Name: 3.5MM CORTEX SCREW SELF-TAPPING 24MM
• 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: 10019173
• MDR Text Key: 190003010
• Report Number: 2939274-2020-02214
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886982146304
• UDI-Public: (01)10886982146304
• 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
• 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: 204.824
• Device Catalogue Number: 204.824
• Device Lot Number: 46P1090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1