MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPEEDTITAN COMPRESSION IMPLANT KIT 18X18X18MM; STAPLE, FIXATION, BONE

Model Number	SE-1818TI
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is unknown.Date of event: unknown.Implant date: unknown.Device has not been reported as explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter phone and email address were not reported.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 the patient had a post-operative visit on or about (b)(6) 2018, it was found that one of the two biomedical enterprises staple (bme staple) was broken.Bme staples were implanted on an unknown date.Revision surgery will be scheduled.Patient outcome is unknown.This is report 1 of 1 for (b)(4).

• Brand Name: SPEEDTITAN COMPRESSION IMPLANT KIT 18X18X18MM
• 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: 7620226
• Report Number: 2939274-2018-52560
• Device Sequence Number: 1694649
• Product Code: JDR
• UDI-Device Identifier: 00810633021538
• UDI-Public: (01)00810633021538
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/25/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SE-1818TI
• Device Catalogue Number: SE-1818TI
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 06/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention