MAUDE Adverse Event Report: IN2BONES, USA COLAG; SINGLE USE INSTRUMENT KIT

Model Number	P06 S0004
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Affected devices were discarded after the case.No additional investigation is available.
Event or Problem Description
It was reported that during a midfoot fusion procedure, the 2.7 mm cannulated drill was placed over the 0.062 " x 6 " guide wire from the single-use instrument kit.The distal portion of the drill and wire broke off and were left inside the patient.They were unable to be retrieved.Device history records were reviewed, and they showed the devices were manufactured to specifications.The instrumentation was discarded post-op, so the product was not available for evaluation.The surgeon stated there was no interference or anomalies felt during the drilling or use of the wire.At the time of the incident, no other hardware was in the patient.It was estimated by the surgeon the drill was about 1 cm deep in the bone at the time of the fracture.No known patient adverse effects have been reported to date.

• Brand Name: COLAG
• Common Device Name: SINGLE USE INSTRUMENT KIT
• Manufacturer (Section D): IN2BONES, USA; 6000 poplar ave; suite 115; memphis TN 38119
• Manufacturer (Section G): IN2BONES, USA; 6000 poplar ave; suite 115; memphis TN 38119
• Manufacturer Contact: robert buchanan ; 6000 poplar ave; suite 115; memphis, TN 38119 ; 9012607931
• MDR Report Key: 13212646
• Report Number: 3011580264-2021-00004
• Device Sequence Number: 1534537
• Product Code: LXH
• UDI-Device Identifier: 00810021866086
• UDI-Public: 010081002186608617260816101133931
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K170518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2022

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: 08/16/2026
• Device Model Number: P06 S0004
• Device Catalogue Number: P06 S0004
• Device Lot Number: 1133931
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown