MAUDE Adverse Event Report: DEPUY MITEK LLC US TIBIAL GUIDE BULLET; SUTURE/NEEDLE PASSER, REUSABLE

Model Number	219390
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device lot number and manufacture date are unknown.Udi: (b)(4).Investigation summary: according to the information provided, it was reported that during an anterior cruciate ligament reconstruction the tibial guide bullet welded itself.The sales rep assumes that it was because the heat created after several attempts of turning the bullet due to hard bone of the patient.The complaint device was received and evaluated, upon visual inspection, it was observed that the drill is jammed inside the bullet guide.The guide has no structural anomalies.Given that lot number was not provided, the manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual results, this complaint can be confirmed.A possible root cause can be attributed to procedural variables, such handling of the device or product interaction during procedure; the drill is jammed due to prolonged drilling action.As per ifu 108529: end of useful instrument life is generally determined by wear or damage from handling or surgical use.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.Device history lot: given that lot number was not provided, the manufacturing record evaluation (mre) review cannot be performed.
Event or Problem Description
It was reported by the sales rep via phone that during an anterior cruciate ligament reconstruction the tibial guide bullet welded itself.Another device was used to complete the procedure.During an in house engineering evaluation it was determined that the device was jammed/seized.No patient consequences or surgical delay reported.No additional information was provided.

• Brand Name: TIBIAL GUIDE BULLET
• Common Device Name: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13078276
• Report Number: 1221934-2021-03833
• Device Sequence Number: 5823560
• Product Code: LXH
• UDI-Device Identifier: 10886705006199
• UDI-Public: 10886705006199
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/23/2021

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: 219390
• Device Catalogue Number: 219390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown