MAUDE Adverse Event Report: STRYKER GMBH CONVEX SURFACING REAMER EASYCLIP Ø20MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	XFR004220
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that: "we had an incident today where one of the anchorage 1 reamers caused harm to the patient by damaging the bone, resulting in a need for a bone graft.It seems the reamers used were blunt." "mtp fusion surgery, began reaming of the proximal phalanx and as the reamer came into contact with the bone it caused the distal 2/3's of the proximal phalanx on the dorsal aspect to become damaged".
Additional Manufacturer Narrative
The reported event could not be confirmed since no functional issue could be detected with the returned reamers.The device inspection revealed the following: one 20mm and one 22mm convex surfacing reamer were returned for evaluation.Both items are in a used condition with slight signs of wear, at first glance the cutting edges of both items are fine.Both devices do not have the color coding (orange for 20mm and red for 22mm) which is part of the design since the year 2011, which shows that both devices are older than 14 years.The closer inspection of the cutting edges has shown that the 20mm reamer is in a good condition, there is no indication for any device related issue that could lead to a reduced cutting performance.A functional test with a power tool, guide wire and test material with the same properties as bone was conducted.The cutting performance of the 20mm reamer was very good, which is also indicated by the elongated, uninterrupted shavings that were created.The complaint history was reviewed for the reported catalog numbers of the returned parts and apart from pi 3978714 are no other complaints in relation to worn/blunt devices registered for the affected catalog numbers.Pi 3978714 was the follow up complaint from the same hospital, where their remaining reamers were returned as they were potentially blunt, the complaint was rated as unconfirmed.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.No product related issue could be detected, the root cause of the reported event could not be defined as the returned 20mm reamer is functional as required.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that: "we had an incident today where one of the anchorage 1 reamers caused harm to the patient by damaging the bone, resulting in a need for a bone graft.It seems the reamers used were blunt." "mtp fusion surgery, began reaming of the proximal phalanx and as the reamer came into contact with the bone it caused the distal 2/3's of the proximal phalanx on the dorsal aspect to become damaged".

• Brand Name: CONVEX SURFACING REAMER EASYCLIP Ø20MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22087666
• Report Number: 0008031020-2025-00933
• Device Sequence Number: 18148243
• Product Code: HWE
• UDI-Device Identifier: 07613252265726
• UDI-Public: 07613252265726
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2025

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 Catalogue Number: XFR004220
• Device Lot Number: C0908940900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown