MAUDE Adverse Event Report: IN2BONES, USA 5MS; T7 DRIVER

Model Number	P06 S0021
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that dring a procedure, a driver tip broke off into a locking screw.The surgeon was unable to remove the tip from the head of the screw.The surgeon attempted to remove the tiop without success.A review of the product device history record indicated there were no non-conformances and the parts were manufacured to specifications.The product was disposed of at the hospital and was not available for evaluation.There has been no patient complication reported to-date.
Additional Manufacturer Narrative
No device problems were identified through the product device history record.

• Brand Name: 5MS
• Common Device Name: T7 DRIVER
• Manufacturer (Section D): IN2BONES, USA; 6000 poplar avenue; suite 115; memphis TN 38119
• Manufacturer (Section G): IN2BONES, USA; 6000 poplar avenue; suite 115; memphis TN 38119
• Manufacturer Contact: robert buchanan ; 6000 poplar avenue; suite 115; memphis, TN 38119 ; 9012607931
• MDR Report Key: 15047451
• Report Number: 3011580264-2022-00002
• Device Sequence Number: 5601675
• Product Code: LXH
• UDI-Device Identifier: 00810021861869
• UDI-Public: (01)00810021861869(17)260310(10)1051191
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2022

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: 03/10/2026
• Device Model Number: P06 S0021
• Device Lot Number: 1051191
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: P64 ST412 - 2.4X12MM LOCKING SCREW, LOT GM002584
• Patient Sex: Female