MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM CORTEX SCREW SELF-TAPPING 40MM; SCREW, FIXATION, BONE

Model Number 214.840

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Occupation: initial reporter is synthes sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.Product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot part # 214.840, synthes lot # 57p2610, supplier lot # na, release to warehouse date: 21 may 2020, manufactured by (b)(4), no ncr's were generated during production.Device history review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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 devices were discovered as damaged after the sales consultant received the item shipments.Multiple packages were broken with the screws reported as flattened.There was no patient involvement.This report is for one (1) 4.5mm cortex screw self-tapping 40mm.This is report 3 of 3 for (b)(4).

• Brand Name: 4.5MM CORTEX SCREW SELF-TAPPING 40MM
• 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 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10448769
• MDR Text Key: 204233042
• Report Number: 2939274-2020-03774
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886982154699
• UDI-Public: (01)10886982154699
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PRE-AMEND
• 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: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 214.840
• Device Catalogue Number: 214.84
• Device Lot Number: 57P2610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 2.5MM DRILL TIP GUIDE WIRE 200MM.; 4.3MM DRILL BIT/QC/180MM.; 4.5MM VALCP CRV CNDY PLT/8H/195MM/RT.; 5.0MM VBLANG LCK SCR/SLF-TP30MM.; 5.0MM VBLANG LCK SCR/SLF-TP55MM.