MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 6MM FBALL,L; MOTOR, DRILL, ELECTRIC - CUTTING BURR

Model Number	L-6B-G1
Medical Device Problem Codes	Device-Device Incompatibility (2919); 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 the initial medwatch, a follow-up medwatch will be filed as appropriate.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Concomitant medical devices and therapy dates: cutter device, attachment device, handpiece device; (b)(6) 2021.Udi: (b)(4).
Event or Problem Description
This is report 2 of 3 for the same event.It was reported that during an instrument check, it was observed that the attachment device while being used with two cutter devices could not be attached to the handpiece device.It was further reported that the devices ran hot.This 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 will be submitted accordingly.
Additional Manufacturer Narrative
Product complaint # (b)(4) 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: upon follow up with the reporter, it was determined that the reported condition of "the attachment device while being used with two cutter devices could not be attached to the handpiece device", is not associated with this event and is only associated with the report that the devices ran hot.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: the actual device was returned for evaluation.During evaluation it was determined that the device passed all manufacturing specifications.Therefore, the reported condition could not be duplicated nor confirmed.An assignable root cause was not determined.

• Brand Name: 6MM FBALL,L
• Common Device Name: MOTOR, DRILL, ELECTRIC - CUTTING BURR
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11841573
• Report Number: 1045834-2021-00818
• Device Sequence Number: 11018082
• Product Code: HBC
• UDI-Device Identifier: 00845384012948
• UDI-Public: 00845384012948
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K113476
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/23/2021

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 Expiration Date: 08/09/2024
• Device Model Number: L-6B-G1
• Device Catalogue Number: L-6B-G1
• Device Lot Number: N313138250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 05/27/2021; 07/23/2021; 08/11/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 06/02/2021; 07/27/2021; 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1