MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 9.2MM FACN,SHD; DRILLS, BURRS, TREPHINES AND ACCESSORIES (SIMPLE, POWERED)

Catalog Number	SHD-9AC-G1
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Concomitant med products: handpiece device.Device history review: the actual device was not returned for evaluation; therefore, the reported condition was not confirmed.However, a device history review was performed which indicated that there were no non-conformance or abnormalities identified during the manufacture of the device that may have contributed to the reported condition.It was determined that the device passed all manufacturing and test requirements at the time of manufacture.Complaint history review: a complaint history review was performed which indicated that there were no complaints found for the reported lot number.Manufacturing record evaluation (mre) review: a manufacturing record evaluation (mre) was performed for the finished device lot number, and there were no non-conformances identified that was related to the reported complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi ¿ (b)(4).
Event or Problem Description
It was reported from (b)(6) that during pre-surgery testing it was observed that the proximal end of the cutter device shaft broke when used with a handpiece device.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was not reported, however, it was reported that the event occurred in 2020.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 9.2MM FACN,SHD
• Common Device Name: DRILLS, BURRS, TREPHINES AND ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10580143
• Report Number: 1045834-2020-01525
• Device Sequence Number: 2961929
• Product Code: HBE
• UDI-Device Identifier: 00845384012917
• UDI-Public: 845384012917
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K113476
• 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
• Report Date (Section B): 09/10/2020

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 Expiration Date: 02/28/2024
• Device Catalogue Number: SHD-9AC-G1
• Device Lot Number: N123136406
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1