MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPEEDSHIFT(TM) IMPLANT KIT 15 X 15 MM, OFFSET 6 MM; STAPLE,FIXATION,BONE

Model Number	SE-1520-06
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event occurred on an unknown date 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.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 during 2020 audit, the speed shift implant kit was found to be ineffective.It was observed that the compression staple fell out of its inserter.There was no patient involvement.This report is for 1 speedshift(tm) implant kit 15 x 15 mm, offset 6 mm.This is report 1 of 1 for (b)(4).

• Brand Name: SPEEDSHIFT(TM) IMPLANT KIT 15 X 15 MM, OFFSET 6 MM
• Common Device Name: STAPLE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10839588
• Report Number: 2939274-2020-05151
• Device Sequence Number: 3799630
• Product Code: JDR
• UDI-Device Identifier: 00810633020425
• UDI-Public: (01)00810633020425
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K142292
• 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): 10/19/2020

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-1520-06
• Device Catalogue Number: SE-1520-06
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 11/13/2020
• Patient Sequence Number: 1