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

Model Number N/A

Device Problems Fracture (1260); Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2021

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 292349091
• Report Number: 0001825034-2022-01259
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00880304677289
• UDI-Public: (01)00880304677289(17)300918(10)792670
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K132239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 96 KG