MAUDE Adverse Event Report: ARTHREX, INC. DPTH DEV, CANN SCRWS; DEPTH GAUGE

Model Number	DPTH DEV, CANN SCRWS
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Codes	Bacterial Infection (1735); Insufficient Information (4580)
Date of Event	11/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 5th dec 2025, it was reported by an arthrex's employee via an email that for 1 unit of ar-8750-01, depth device for cannulated screws, blood clot was found in the instrument depth gauge.This was detected during a spring ligament recon procedure on (b)(6) 2025.The surgeon continued using the ar-8750-01 after soaking it in chlorhex.Additional information: the hospital informed arthrex singapore on (b)(6) 2025 that the patient suffered from side effect after the surgery.Additional information received on 10th dec 2025: the patient went back to the hospital for wound washout 3 times due to infection.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on photographic evidence showing an ar-8750-01, batch 04511846, with a blood clot present in the depth gauge.Based on the information provided ¿ which may include the returned device (if available), photographs, videos, event description, and any additional field input ¿ arthrex has determined the most likely cause.The most likely cause is attributed to misuse due to an improper cleaning method.Without proper sterilization, the contamination likely created an infection risk.
Event or Problem Description
On 5th dec 2025, it was reported by an arthrex employee via an email that for 1 unit of ar-8750-01, depth device for cannulated screws, blood clot was found in the device.This was detected during a spring ligament recon procedure on (b)(6) 2025.The surgeon continued using the device after soaking it in chlorhex and rubbing it with gloved hands.Arthrex singapore was informed by the hospital on (b)(6) 2025 that the patient suffered from side effect after the surgery.It was further updated on (b)(6) 2025 that the patient presented to hospital with a swollen wound and yellow discharge and went for 3 wound washouts.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.A complaint analysis was performed, and the allegation was confirmed based on photographic evidence, which reportedly shows the device before it was soaked in chlorhexidine and rubbed with gloved hands, revealing an ar-8750-01, batch 04511846, with debris present on the device.No confirmatory analysis was performed to verify that the debris was blood.Based on the information provided ¿ which may include the returned device, photographs, videos, event description, and any additional field input ¿ arthrex has determined that: (1) the most likely cause of the debris in the device is due to improper or insufficient cleaning after the time debris was noted on the device, and (2) only using chlorhex and rubbing with gloved hands is not consistent with the complete cleaning and/or sterilization method stated in our dfu-0023-eo.Arthrex cannot confirm the effectiveness of the cleaning method used, as it deviates from the prescribed protocol.Without additional information, we cannot conclude whether using that method caused the swollen wound and yellow discharge.Per dfu-0023-eo revision 4 d.Cleaning and disinfection: "all devices are to be cleaned, disinfected, and sterilized prior to each application; this is required as well for the first use after delivery of the non-sterile devices.Effective cleaning is an indispensable requirement for effective sterilization of the devices.

• Brand Name: DPTH DEV, CANN SCRWS
• Common Device Name: DEPTH GAUGE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 23779822
• Report Number: 1220246-2025-05592
• Device Sequence Number: 18640176
• Product Code: HTJ
• UDI-Device Identifier: 00888867263604
• UDI-Public: (01)00888867263604(11)181116(10)04511846
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: DPTH DEV, CANN SCRWS
• Device Catalogue Number: AR-8750-01
• Device Lot Number: 04511846
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 12/29/2025; 01/14/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 01/05/2026; 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown