MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM CORTEX SCREW SELF-TAPPING 30MM; SCREW, FIXATION, BONE

Model Number	214.830
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 or Problem Description
It was reported that on an unknown date, there was a non union due to unspecified cause.Original date of surgery was on (b)(6) 2020 of a five (5) broken 4.5mm cortex screw self-tapping, one (1) 4.5mm va-lcp curved condylar plate, and six (6) cannulated va locking screw.We operated to a non-union and placed a new unknown plate and a unknown nail.All broken implant fragments were removed easily with no delay.Procedure was successfully completed.Patient was stable.Concomitant device reported: 4.5mm va-lcp curved condylar plate/16 hole/336mm/left (part# 02.124.417; lot# :8915402; quantity: 1), 5.0mm cannulated va locking screw/85mm (part# 02.231.685 ; lot# unknown; quantity: 6).This report is for one (1) 4.5mm cortex screw self-tapping 30mm.This is report 1 of 5 for (b)(4).

• Brand Name: 4.5MM CORTEX SCREW SELF-TAPPING 30MM
• 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: 10711840
• Report Number: 2939274-2020-04746
• Device Sequence Number: 11689629
• Product Code: HWC
• UDI-Device Identifier: 10886982154644
• UDI-Public: (01)10886982154644
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: PRE-AMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 214.830
• Device Catalogue Number: 214.83
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 10/21/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR
• Patient Weight: 91