MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPEED COMPRESSION IMPLANT KIT 09X10X10MM; BONE STAPLE

Model Number	SE-0910
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient age/date of birth and weight are unknown.The malunion occurred on an unknown date in 2018.Complainant part is not expected to be returned for manufacturer review/investigation, as it was reportedly discarded.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 on (b)(6) 2018, the patient underwent revision surgery due to malunion.Two (2) speed compression implants were originally implanted on (b)(6) 2018.Devices were removed and revised with a plate and screws.There was no surgical delay and the procedure was successfully completed.This is report 2 of 2 for (b)(4).

• Brand Name: SPEED COMPRESSION IMPLANT KIT 09X10X10MM
• 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: 7568980
• Report Number: 2939274-2018-52404
• Device Sequence Number: 1317257
• Product Code: JDR
• UDI-Device Identifier: 00810633020111
• UDI-Public: (01)00810633020111
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: SE-0910
• Device Catalogue Number: SE-0910
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 06/05/2018
• 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