MAUDE Adverse Event Report: TYBER MEDICAL TYFIX

Model Number	M13-S20113-S
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history record review was performed for lot 1226013 and there were no non-conformance's related to this complaint type.The lot met all release requirements.At the time of the investigation, capa (b)(4) was initiated for the tyfix break to ensure appropriate corrective actions are taken.No trend was detected for this event type.The product was not returned for evaluation.Therefore, an evaluation of the actual device could not be performed.Simulation studies were performed using similar parts (part # 413-s20113-s (lot#:124402 and 124403) and 413-c20013-s (lot#:124401).The simulations were able to recreate the failure only when the implant was supported at the wrong location, which suggested that user error may have been a contributing factor to this event.Complaints of this nature are monitored through tracking and trending.Should a trend arise, further action will be taken.Complaint #: (b)(4).
Event or Problem Description
Customer reported on (b)(6) 2018 during a surgical procedure, as the surgeon was driving the implant in the proximal phalanx, the implant broke off.A portion of the implant was left in the patient.No patient harm was reported.Product will be returned for evaluation.

• Brand Name: TYFIX
• Common Device Name: TYFIX
• Manufacturer (Section D): TYBER MEDICAL; 83 s. commerce way; suite 310; bethlehem PA 18017
• MDR Report Key: 8688598
• Report Number: 3012966183-2018-00001
• Device Sequence Number: 19474620
• Product Code: HWC
• UDI-Device Identifier: M695M13S20113S0
• UDI-Public: M695M13S20113S0
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: 1570571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/20/2018

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: No Information
• Device Expiration Date: 07/26/2023
• Device Model Number: M13-S20113-S
• Device Catalogue Number: M13-S20113-S
• Device Lot Number: 122603
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 06/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1