MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SRVC REPL DYONICS BATTERY HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	72204114S
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the motor heated.No case involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10, h3, h6: the device, which was not used in a procedure, was returned for evaluation.There was no relationship between the reported event and the device.Visual assessment of the device showed no damage to the drill.Functional inspection was performed and showed the drill functioned as intended.No overheating was observed.This device was manufactured in aug 2016.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found no related failures.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.No manufacturing related defects were observed.
Additional Manufacturer Narrative
H10 h6: the device, which was not used in a procedure, was not returned for evaluation.Visual inspection and functional testing could not be performed.A relationship, if any, between the device and the reported incident could not be confirmed.

• Brand Name: SRVC REPL DYONICS BATTERY HANDPIECE
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 9837831
• Report Number: 3003604053-2020-00014
• Device Sequence Number: 3375028
• Product Code: HWE
• UDI-Device Identifier: 00885554037142
• UDI-Public: 00885554037142
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/03/2020

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: 72204114S
• Device Catalogue Number: 72204114S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 04/15/2020; 07/31/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 04/22/2020; 08/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1