MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PATHWAY IM DRILL 9MM; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS

Model Number 2178-56-045

Device Problem Off-Label Use (1494)

Patient Problems Fall (1848); Limb Fracture (4518)

Event Date 01/04/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Wrong instrument was provided in the instrument set.Probably due to a misdirection of the drill bit during its passage and accentuated by the pointed end of this instrument, the surgeon crossed the anterior cortex of the femur.Unfortunately, during the night, the patient fell out of bed and fractured her femur at this fragile point.This resulted in a second surgical intervention.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: PATHWAY IM DRILL 9MM
• Type of Device: DRILLS (BITS, SLEEVES, GUIDES) : DRILLS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13293085
• MDR Text Key: 286877057
• Report Number: 1818910-2022-01205
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295095460
• UDI-Public: 10603295095460
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2178-56-045
• Device Catalogue Number: 217856045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention