MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPEED COMPRESSION IMPLANT KIT 11X10X10MM; BONE STAPLE

Model Number	SE-1110
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event date is unknown in 2020.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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, neither of the two (2) speed compression plate, one (1) speed compression implant sizing guide, one (1) speed drill kit after they were deployed from the inserter the legs stayed straight and did not compress at all.There was no surgical delay.The procedure was successfully completed.There was no patient consequence.Concomitant device reported: unknown insertion (part # unknown, lot # unknown, quantity # 1).This complaint involves two (2) devices.This is 2 of 2 for report (b)(4).

• Brand Name: SPEED COMPRESSION IMPLANT KIT 11X10X10MM
• Common Device Name: BONE STAPLE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9861419
• Report Number: 2939274-2020-01419
• Device Sequence Number: 19529741
• Product Code: JDR
• UDI-Device Identifier: 00810633020128
• UDI-Public: (01)00810633020128
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2020

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: SE-1110
• Device Catalogue Number: SE-1110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2020
• Initial Report FDA Received Date: 03/20/2020
• Patient Sequence Number: 1
• Patient Age: 48 YR