MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP BROACH EXTRACTOR TOOL TOOL

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.
Event or Problem Description
It was reported that surgeon tried to remove the rasp in the humeral canal and the instrument broke.The patient did not retain a foreign body.No further information available at the time of this reporting.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Corrected: no adverse event has occurred as a result of this malfunction visual examination confirms the reported material fracture.Dimensional analysis confirms the device conforms to its specifications.Review of device history records found these units were released to distribution with no deviations or anomalies.Root cause is unknown.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further information available at the time of this reporting.

• Brand Name: COMP BROACH EXTRACTOR TOOL TOOL
• Common Device Name: EXTRACTOR
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9175367
• Report Number: 0001825034-2019-04555
• Device Sequence Number: 2812076
• Product Code: HWB
• UDI-Device Identifier: 00880304456808
• UDI-Public: 00880304456808
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 407393
• Device Lot Number: 179740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention