MAUDE Adverse Event Report: SYNTHES GMBH CANNULATED REAMER DISTAL/24MM

Catalog Number	03.211.024
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that following a procedure on (b)(6) 2021, the cannulated foot reamers were blunt.There was no patient consequence.This report is for a cannulated reamer.This is report 15 of 20 for (b)(4).Additional reports are captured under (b)(4).
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Date of concomitant devices is (b)(6) 2021.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CANNULATED REAMER DISTAL/24MM
• Common Device Name: REAMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13081617
• Report Number: 8030965-2021-10448
• Device Sequence Number: 4998348
• Product Code: HTO
• UDI-Device Identifier: 07611819434912
• UDI-Public: (01)07611819434912
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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 Catalogue Number: 03.211.024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2021
• Initial Report FDA Received Date: 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CANNULATED DISTAL REAMER Ø18; CANNULATED DISTAL REAMER Ø18; CANNULATED DISTAL REAMER Ø18; CANNULATED DISTAL REAMER Ø20; CANNULATED DISTAL REAMER Ø20; CANNULATED DISTAL REAMER Ø20; CANNULATED DISTAL REAMER Ø22; CANNULATED DISTAL REAMER Ø22; CANNULATED DISTAL REAMER Ø22; CANNULATED DISTAL REAMER Ø24; CANNULATED DISTAL REAMER Ø24; CANNULATED PROXIMAL REAMER Ø18; CANNULATED PROXIMAL REAMER Ø18; CANNULATED PROXIMAL REAMER Ø18; CANNULATED PROXIMAL REAMER Ø20; CANNULATED PROXIMAL REAMER Ø20; CANNULATED PROXIMAL REAMER Ø20; CANNULATED PROXIMAL REAMER Ø22; CANNULATED PROXIMAL REAMER Ø22; CANNULATED PROXIMAL REAMER Ø22; CANNULATED PROXIMAL REAMER Ø24; CANNULATED PROXIMAL REAMER Ø24; CANNULATED PROXIMAL REAMER Ø24
• Patient Sex: Unknown