MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 7MM MINI MINI; PROSTHESIS SHOULDER

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Codes	No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical product: catalog #: 407398, comp primary stem inserter, lot # 287480; catalog #: unknown, reverse tray, lot # unknown.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during a comprehensive reverse total shoulder procedure a humeral stem could not be attached to the inserter.The stem was inserted by hand, and then the humeral tray would not engage the stem.The stem was then removed.Additional broaching was required and a larger size stem was used to complete the procedure.
Additional Manufacturer Narrative
(b)(4).Updated: b1, b4, b5, g3, h1, h2, h3, h6, h10.Complaint was confirmed by visual examination of the returned product which identified that there is extensive damage to the stem in terms of scratches and taper damage.The inserter is missing the spring that holds tension to the rod that holds the stem.The set screw that holds the spring into place in the inserter was loose and does not show any signs of the epoxy anymore.Inside the inserter where the set screw is installed does not show any signs of epoxy as well.The inserter was manufactured in may of 2018.The stem and the inserter do mate as intended but the trigger had to be pushed towards the stem since the spring is missing.Device history record was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue is attributed to user error as the spring was missing from the inserter causing it to not function.This should have been identified prior to the procedure and/or during reprocessing.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 event information available at the time of this report.

• Brand Name: COMP PRIMARY STEM 7MM MINI MINI
• Common Device Name: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11046255
• Report Number: 0001825034-2020-04382
• Device Sequence Number: 19091132
• Product Code: HSD
• UDI-Device Identifier: 00880304462656
• UDI-Public: (01)00880304462656(17)290314(10)488500
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K060692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2021

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: 113627
• Device Lot Number: 488500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 05/07/2021
• 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: Other; Required Intervention