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

Model Number	214.840
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10448769
• Report Number: 2939274-2020-03774
• Device Sequence Number: 3903443
• Product Code: HWC
• UDI-Device Identifier: 10886982154699
• UDI-Public: (01)10886982154699
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: PRE-AMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 214.840
• Device Catalogue Number: 214.84
• Device Lot Number: 57P2610
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 08/25/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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.