MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 22MM; SCREW, FIXATION, BONE

Model Number	204.822
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional product codes: hrs, jds.Complainant part is not expected to be returned for manufacturer review.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.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.Device was discarded per reporter.Device was used for treatment, not diagnosis.
Event or Problem Description
Updated event description: it was reported that on (b)(6) 2018, the patient underwent a hardware removal procedure due to pain.There were (1) locking compression plate (lcp) tubular plate with collar, one (1) variable angle lcp medial distal tibia plate, seven (7) cortex screws, two (2) locking screws with stardrive and five (5) variable angle locking screws with t8 stardrive were removed.The hardware was implanted on an unknown date.During the procedure the five (5) variable angle locking screws broke.The broken screws were fully removed.The bone was healed and no additional hardware was placed.The surgery was successfully completed with no surgical delay.The patient outcome is unknown.The linked complaint (b)(4) for the additional six devices this complaint involves ten 10 of the 16 devices.This complaint is for one 3.5mm cortex screw self-tapping 22mm.This report is 1 of 10 for (b)(4).

• Brand Name: 3.5MM CORTEX SCREW SELF-TAPPING 22MM
• 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: 7975974
• Report Number: 2939274-2018-54426
• Device Sequence Number: 13873488
• Product Code: HWC
• UDI-Device Identifier: 10886982146298
• UDI-Public: (01)10886982146298
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K131186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/02/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 204.822
• Device Catalogue Number: 204.822
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 10/17/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Weight: 72