MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP NLK SCR 3.5HEX 4.75X35 ST; PROSTHESIS, SHOULDER

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Year of birth: (b)(6).Concomitant medical products: 180563 187570 comp nlk scr 3.5hex 4.75x45 st 110040301 750520 compr aug mini 3.5 hex driver 110010424 783980 comp rvs 3.5mm hex driver.Report source: foreign country: (b)(6).The device was received and submitted for analysis.Sem analysis determined that the comp non-locking screw sample fractured due to torsional overload.Suspected crack initiation region identified on the fracture surface.Sheared ductile overload dimples identified near the crack initiation region.Fracture showed torsional overload mode of fracture throughout exhibiting sheared ductile dimples.Eds semi-quantitative elemental analysis of the non-locking screw showed that it was consistent with ti-6al-4v alloy.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported when inserting the inferior screw, the screw could not be fully countersunk.Removing the screw was also difficult.Pliers from the operating room had to be used because the screwdrivers did not grip the screw head.A defect in the screwdriver could have been the cause.When inserting the superior screw, the screw head got broken.The rest of the screw was left in place and the remaining 3 peripheral screw holes were filled.All screw holes were adequate in depth.The screw was returned fractured.No adverse events have been reported as a result of this malfunction, attempts have been made and additional information on the reported event is unavailable.

• Brand Name: COMP NLK SCR 3.5HEX 4.75X35 ST
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14462277
• Report Number: 0001825034-2022-01259
• Device Sequence Number: 4685565
• Product Code: KWS
• UDI-Device Identifier: 00880304677289
• UDI-Public: (01)00880304677289(17)300918(10)792670
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K132239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2022

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: N/A
• Device Catalogue Number: 180561
• Device Lot Number: 792670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Patient Sex: Male
• Patient Weight: 96 KG