MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 11.0 CM LONG ATTACHMENT; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC)

Model Number	LONG-G1
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.The surgeon¿s phone number was not provided.However, the reporter¿s name, phone number and email address were provided as (b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi: (b)(4).
Event or Problem Description
It was reported from (b)(6) that during a general checkup, post implantation for an anterior cervical fusion procedure, it was discovered that the attachment device heated up.It was reported that there were no delays to the surgical procedure, and the surgery was completed as intended.The event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.H10 additional narrative: during repair, an evaluation was performed, and it was determined that the reported condition was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was determined that the cutter device could not be inserted.It was further determined that the device failed pretest for cutter insertion.The assignable root cause was determined to be due to component failure from normal wear.

• Brand Name: 11.0 CM LONG ATTACHMENT
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC)
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11641120
• Report Number: 1045834-2021-00586
• Device Sequence Number: 11510187
• Product Code: ERL
• UDI-Device Identifier: 00845384016335
• UDI-Public: 00845384016335
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K011444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2021

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: LONG-G1
• Device Catalogue Number: LONG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1