MAUDE Adverse Event Report: EMBODY, INC EMBODY DUAL ANCHOR INSERTER, BIOABSORBABLE ANCHORS; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	TR-0001-21
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while prepping for surgery, the circulating nurse noted the needles extending in the packaging, causing a puncture in the package.This was noted outside of the sterile field, so no patient was involved in the event.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information 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 further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6.Visual examination of the provided photograph identified a puncture hole in the foil foil packaging.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported issue is attributed to manufacturing.The event was confirmed.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: EMBODY DUAL ANCHOR INSERTER, BIOABSORBABLE ANCHORS
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): EMBODY, INC; 4211 monarch way, suite 500; norfolk VA 23508
• Manufacturer (Section G): EMBODY, INC; 4211 monarch way, suite 500; norfolk VA 23508
• Manufacturer Contact: jennifer rapsavage ; 56 e bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23425169
• Report Number: 3015543569-2025-00004
• Device Sequence Number: 9536461
• Product Code: MAI
• UDI-Device Identifier: 00810063820152
• UDI-Public: (01)00810063820152(17)251016(10)052580
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K213958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2026

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 Expiration Date: 10/16/2025
• Device Catalogue Number: TR-0001-21
• Device Lot Number: 052580
• Was Device Available for Evaluation?: No
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2025
• 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: NI
• Patient Sequence Number: 1
• Patient Sex: Unknown