MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM TI VAL METACARPAL NECK PLATE-STERILE; PLATE,FIXATION,BONE

Model Number	04.130.268S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2019
Type of Reportable Event	Malfunction
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 (b)(6) 2019, two (2) of the distal holes on the titanium metacarpal neck plate did not seem to work during an open reduction internal fixation of the fifth (5th) metacarpal.The surgeon thought it was defective since the screw would only spin, and not attach into the plate to lock.There was a surgical delay of five to ten (5-10) minutes.Procedure was successfully completed.Patient status is unknown.Concomitant devices reported: unknown cortex screws (part # unknown, lot # unknown, quantity unknown); unknown locking screws (part # unknown, lot # unknown, quantity unknown); unknown modular hand (part # unknown, lot # unknown, quantity unknown).This report is for one (1) 1.5mm ti val metacarpal neck plate-sterile.This is report 1 of 1 for (b)(4).

• Brand Name: 1.5MM TI VAL METACARPAL NECK PLATE-STERILE
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8361466
• Report Number: 2939274-2019-56594
• Device Sequence Number: 11339458
• Product Code: HRS
• UDI-Device Identifier: 10886982113238
• UDI-Public: (01)10886982113238
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/29/2019

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: 04.130.268S
• Device Catalogue Number: 04.130.268S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 02/22/2019
• Patient Sequence Number: 1