MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5 MM LOCKING SCREW 38 MM LENGTH; TRAUMA, IMPLANT

Model Number	N/A
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item# 00235905036; lot# 62910256; 3.5 mm cannulated locking screw 50 mm length.Item# 00235902835; lot# 64264551; 3.5 mm locking screw 28 mm length.Item# 00235904536; lot# 64494587; 3.5 mm cannulated locking screw 45 mm length.Item# 00235904536; lot# 64793583; 3.5 mm cannulated locking screw 45 mm length.Item# 00235903035; lot# 64661162; 3.5 mm locking screw 30 mm length.Item# 00235800106; lot# 63754197; proximal lateral humeral plate right 6 holes 114 mm length.Report source: foreign: event occurred in (b)(6).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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00226, 0001822565-2021-00227, 0001822565-2021-00228, 0001822565-2021-00230, 0001822565-2021-00231, 0001822565-2021-00232.
Event or Problem Description
It was reported that the patient underwent an initial surgery and had a proximal humeral plate implanted and had postoperative pain.Subsequently, patient was revised because all the locking screws loosened and backed out and one cannulated screw was fractured.Attempts have been made and additional information on the reported event is unavailable.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The locking screws were returned for evaluation and found to be conforming to print specifications.Review of the device history records identified no deviations or anomalies during manufacturing.Radiographs and interoperative photos were provided, however, the image quality was too poor to provided sufficient analysis for investigation.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
No additional information reported.

• Brand Name: 3.5 MM LOCKING SCREW 38 MM LENGTH
• Common Device Name: TRAUMA, IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11328045
• Report Number: 0001822565-2021-00229
• Device Sequence Number: 19110486
• Product Code: HRS
• UDI-Device Identifier: 00889024058538
• UDI-Public: (01)00889024058538(10)64180778
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2021

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: 00235903835
• Device Lot Number: 64180778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/22/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 02/15/2021
• Supplement Report FDA Received Date: 04/23/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR