MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPEEDSHIFT(TM) IMPLANT KIT 15 X 20 MM, OFFSET 10 MM; BONE STAPLE

Model Number	SE-1520-10
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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) 2020, during foot surgery upon insertion of speedshift implant kit the implant was disconnected from the insertion handle before both legs were in the drill holes.Surgeon had one leg in and was able to use a free elevator to maneuver the other leg into the hole.No additional implant was required.There was 2-5 minutes surgical delay.The procedure was successfully completed.There was patient consequence reported.Concomitant device reported: insertion handle (part# unknown; lot# unknown; quantity: 1).Free elevator (part# unknown; lot# unknown; quantity: 1).This report is for one (1) speedshift(tm) implant kit 15 x 20 mm, offset 10 mm.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H4 device history part #: se-1520-10, synthes lot number: bse180238, supplier lot number: bse180238, release to warehouse date: 19-jun-2018, supplier: (b)(4).Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.B5/d11: only the insertion handle is concomitant.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
Updated concomitant device reported: unk - insertion handle (part# unknown; lot# unknown; quantity: 1).

• Brand Name: SPEEDSHIFT(TM) IMPLANT KIT 15 X 20 MM, OFFSET 10 MM
• 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: 10132965
• Report Number: 2939274-2020-02713
• Device Sequence Number: 2911455
• Product Code: JDR
• UDI-Device Identifier: 00810633020449
• UDI-Public: (01)00810633020449
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K142292
• 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,Followup,Followup
• Report Date (Section B): 05/27/2020

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-1520-10
• Device Catalogue Number: SE-1520-10
• Device Lot Number: BSE180238
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 06/11/2020; 06/23/2020
• Initial Report FDA Received Date: 06/09/2020
• Supplement Report FDA Received Date: 06/23/2020; 07/09/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - FREE ELEVATOR; UNK - INSERTION HANDLE; UNK - INSERTION HANDLE; UNK - FREE ELEVATOR; UNK - INSERTION HANDLE