MAUDE Adverse Event Report: WISHBONE MEDICAL, INC. EPIFIX GROWTH CONTROL SYSTEM; GUIDED GROWTH PLATE

Model Number	PK-EFC0220T
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple mdrs reported for the same patient event, see 3013680140-00002 & 3013680140-00003.During investigation, all manufacturing records were found to be conforming.Root cause identified to be engineering specification error which allowed manufacturing variability and ultimately a thin wall condition.This is the company's first complaint; we have been working with the esig and emdr teams to gain access and have a successful test submission over the past 2 months hence the delay in 30-day reporting.
Event or Problem Description
It was reported that screws pulled through 3 of the epifix plates during surgery.It was reported that this did not affect the outcome of the surgery on the patient.No injury or delay of surgery was reported.3 plates were explanted, remaining 4 plates were implanted successfully.No allegations were reported against the screws or instruments in the procedural kits.This is device 1 of 3 (see 3013680140-2020-00002 & 3013680140-2020-00003 for remaining devices).Device was used for treatment, not diagnosis.

• Brand Name: EPIFIX GROWTH CONTROL SYSTEM
• Common Device Name: GUIDED GROWTH PLATE
• Manufacturer (Section D): WISHBONE MEDICAL, INC.; 2150 north pointe dr; warsaw IN 46582
• MDR Report Key: 10526079
• Report Number: 3013680140-2020-00001
• Device Sequence Number: 1167678
• Product Code: OBT
• UDI-Device Identifier: B562PKEFC0220T0
• UDI-Public: +B562PKEFC0220T0/$$321061123200M
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K182704
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 09/07/2020

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 Expiration Date: 06/11/2021
• Device Model Number: PK-EFC0220T
• Device Catalogue Number: PK-EFC0220T
• Device Lot Number: 23200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 09/12/2020
• 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: Other
• Patient Age: 13 YR
• Patient Weight: 113