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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter is synthes sales representative.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.(b)(4).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 an akin osteotomy following a lapidus procedure.While the surgeon was proceeding to insert the speed compression implant kit, the staple prematurely came off of the inserter and disrupted cortical bone where predrilled.This premature disengagement of the speed compression implant kit staple was also reported as occurring before.They stated that the current staples seem to have a loading difference because of the pressure needed to release from the inserter.The surgeon had to switch to using cannulated screws instead.Procedure outcome is unknown.Patient status is unknown.This report is for one (1) speed compression implant kit 09x10x10mm.This is report 1 of 1 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: 8170983
• Report Number: 2939274-2018-55423
• Device Sequence Number: 11199443
• Product Code: JDR
• UDI-Device Identifier: 00810633020111
• UDI-Public: (01)00810633020111
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/26/2018

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-0910
• Device Catalogue Number: SE-0910
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 12/17/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR