MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP LK SCR 3.5HEX 4.75X40 ST; SCREW, FIXATION

Model Number N/A

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/12/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item# 110032430; lot# 64836356; comprehensive reverse large augmented baseplate.Item# 110010424; lot# 544280; comp rvs 3.5mm hex driver.Item# 113633; lot# 054040; comp primary stem 13mm mini.Item# 110040202; lot# 64092792; compr aug 2.7 drill.Item# 110031869; lot# 64415438; comp aug ream guide bushing.Item# 110040300; lot# 64098467; compr aug mini ream gd screw.Item# 180552; lot# 498840; comp lk scr 3.5hex 4.75x25 st.Item# 180553; lot# 498930; comp lk scr 3.5hex 4.75x30 st.Item# 115397; lot# 279210; comp rvs cntrl 6.5x35mm st/rst.Item# 115323; lot# 360620; comp rvsr shldr glnsp +3 41mm.Item# 115370; lot# 602260; comp rvs tray co 44mm.Item# xl-115366; lot# 875880; acrom xl 44-41 std hmrl brng.Foreign report source: (b)(6).The product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a comprehensive augmented reverse shoulder surgery, after impacting the augmented baseplate and having placed the 6.5 mm central compression screw inside the baseplate, 4 peripheral screws were to be inserted in the baseplate.One of the four screws got stuck in the baseplate and could not be fully inserted with the 3.5mm hex screwdriver and it would not come out either.While trying to get the screw out it broke.The surgery was completed with the broken screw.Attempts have been made and additional information on the reported event is unavailable at this time.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the provided picture identified the screw has fractured within the baseplate.No observations can be made regarding the seating issue with this image.There are no other obvious foreign bodies noted other than the broken screw.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.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 Description

No further event information available at the time of this report.

• Brand Name: COMP LK SCR 3.5HEX 4.75X40 ST
• Type of Device: SCREW, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10927122
• MDR Text Key: 218917884
• Report Number: 0001825034-2020-04133
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00880304677180
• UDI-Public: (01)00880304677180
• Combination Product (y/n): N
• PMA/PMN Number: K130390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 180555
• Device Lot Number: 201290
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR
• Patient Weight: 100