MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 3.2 DRILL BIT QC 145/120; PLATE, FIXATION, BONE

Model Number	71176032
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
It was reported that two (2) 3.2 drills bit qc 145/120 had perforated the sterile packaging, it is apparent the black plastic inserts have dislodged from the clear plastic tube resulting in the sharp tip of the drill perforating the sterile outer packaging.It is unknown whether this problem was noticed in a surgical environment or not; therefore, patient involvement has not been confirmed.
Event or Problem Description
It was reported that, during the set up for a thr, it was noticed that a 3.2 drill bit qc 145/120 had perforated the sterile packaging, it is apparent the black plastic inserts had dislodged from the clear plastic tube resulting in the sharp tip of the drill perforating the sterile outer packaging.Surgery was performed, without any delay, with a back-up device instead.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
H3, h6: the device, intended for use in treatment, was not returned for evaluation but the pictures were reviewed, and the failure mode was confirmed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A complaint history review found related failures for the listed batch; this failure mode will be monitored for future complaints for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Damage during shipping or mishandling could be probable causes of the reported event.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: 3.2 DRILL BIT QC 145/120
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12511110
• Report Number: 1020279-2021-07054
• Device Sequence Number: 3908318
• Product Code: HRS
• UDI-Device Identifier: 03596010302793
• UDI-Public: 03596010302793
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2021

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: 71176032
• Device Catalogue Number: 71176032
• Device Lot Number: 18FTMH094
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 10/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1