MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ELITE COMP IMPL KIT 15X15X15 2 LEGS; BONE STAPLE

Model Number	EL-1515S2
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2021, during a tarso metatarsal second digit fusion procedure, an elite compression implant was deployed before implanting.Surgeon tried to reinstall the elite compression implant to the holder but will not work.Tried to implant elite compression implant without the holder, but ended up distracting the fusion site.Elite compression implant removed.Used 3.0 mm cannulated screws to finish the procedure.The procedure was successfully completed with no surgical delay reported.No patient consequence.This report is for one (1) elite comp impl kit 15x15x15 2 legs.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
(b)(6).Complainant part is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was conducted: part # el-1515s2, synthes lot # mel200172, supplier lot # mel200172, release to warehouse date: 22 mar 2021, supplier: millstone medical.No ncr's were generated during production.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.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.

• Brand Name: ELITE COMP IMPL KIT 15X15X15 2 LEGS
• Common Device Name: BONE STAPLE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): BIO MEDICAL ENTERPRISES INC (BME); 14785 omicron dr # 205; san antonio TX 78245
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12833092
• Report Number: 2939274-2021-06736
• Device Sequence Number: 14612103
• Product Code: JDR
• UDI-Device Identifier: 00810633021675
• UDI-Public: (01)00810633021675
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K150125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/25/2021

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: EL-1515S2
• Device Catalogue Number: EL-1515S2
• Device Lot Number: MEL200172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - GRASPING/HOLDING INSTRUMENTS
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 79 KG