MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TI SCREW ES SINGLE LOADED ANCHOR MAXBRAID; SCREW, FIXATION, BONE

Catalog Number	902569
Medical Device Problem Codes	Fracture (1260); Off-Label Use (1494)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item# 902569; lot# 0002656807.G2: foreign - event occurred in colombia.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
It was reported that during an emergency surgery, ti-screw 3.0 mm anchors were prepared to be used.The sales representative was present and reminded the surgeon before use that the correct technique consists of directly threading the anchor without the need to impact it.Subsequently, it was reported by the contact that it was evident the anchor was initially impacted on the bone and then an attempt was made to thread it, which does not correspond to the indicated procedure.This generated excessive friction and resistance to the advance of the implant, causing mechanical overload and the anchor had fractured.When using a second anchor under similar insertion conditions, the same result of anchor fracturing occurred and the fractured anchor was left within the patient's body.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information 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; h10.Visual examination of the returned product identified sample 1 was returned without any sutures in the handle, just the foam sleeve.The sutures were cut just above the anchor and where the sutures enter the shaft of the device.The anchor has been fractured and not all pieces have been returned.Sample 2 was returned with the sutures and the foam sleeve still in the handle of the device.The anchor of sample 2 has also been fractured and was not returned.Both anchors were returned still located in the distal end of the shaft of the device.No other damage is noted to either device.Measured both items and both were conforming to the print.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to use error.The ti-screw suture anchor surgical technique states: screw in the anchor manually until the horizontal laser etch line is flush with the proximal aspect of the cortical bone.The complaint product was impacted, not screwed in.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: TI SCREW ES SINGLE LOADED ANCHOR MAXBRAID
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23727445
• Report Number: 0001825034-2025-03877
• Device Sequence Number: 13310081
• Product Code: HWC
• UDI-Device Identifier: 00880304432093
• UDI-Public: (01)00880304432093(17)290729(10)0002656807
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K080088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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 Catalogue Number: 902569
• Device Lot Number: 0002656807
• Was Device Available for Evaluation?: Yes
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female