MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC HUDSON REAMING ATTACHMENT F/BPL; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number	530.782
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2020
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.Concomitant med products and therapy dates: (2) battery reciprocator devices, battery reamer/drill device, battery oscillator device, chuck with key device, reaming attachment device, battery device; (b)(6) 2020.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
This is report 6 of 7 for the same event.It was reported from (b)(6) that during an unspecified surgical procedure it was observed that two battery reciprocator devices, a battery reamer/drill device, a battery oscillator device, a chuck with key device, two reaming attachment devices, and a battery device were making abnormal noise and generating heat.It was not reported if there were any delays in the procedure due to the event.It was not reported if there was a spare device available for use.There was patient involvement reported.There were no reports of any 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The actual device was returned for evaluation.The reaming attachment device was evaluated and the reported condition that the device was making an abnormal noise and generating heat was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the device had component damage.The assignable root cause of this condition was determined to be traced to component failure due to normal wear.

• Brand Name: HUDSON REAMING ATTACHMENT F/BPL
• Common Device Name: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10159781
• Report Number: 8030965-2020-04175
• Device Sequence Number: 3184294
• Product Code: GEY
• UDI-Device Identifier: 07611819137226
• UDI-Public: 7611819137226
• 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
• Report Date (Section B): 06/10/2020

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 Catalogue Number: 530.782
• Device Lot Number: L229962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1