MAUDE Adverse Event Report: SYNTHES GMBH REAMING ROD / Ø 3.8MM BALL TIP Ø 3.0MM / 950MM - STERILE; REAMER

Catalog Number	03.233.010S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on an unknown date in 2023, the ball tipped wire in question had melted silicon.There was no reported adverse patient impact.No further information is available.This report is for a reaming rod / ø 3.8mm ball tip ø 3.0mm / 950mm ¿ sterile.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b3: event occurred on an unknown date in 2023.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: initial reporter is a synthes employee.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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.Manufacturing location: supplier ¿ eptam precision metals / inspected, packaged and released by: monument.Release to warehouse date: 22-mar-2023.Expiration date: 28-feb-2033.Part number: 03.233.010s, 3.0mm reaming rod, 950mm - sterile.Lot number: 4112p62 (sterile).Lot quantity: (b)(4).This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the inspection or release of this product that would contribute to this complaint condition.Product was not returned.Based on the information available, it has been determined that no corrective and 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: REAMING ROD / Ø 3.8MM BALL TIP Ø 3.0MM / 950MM - STERILE
• 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18336050
• Report Number: 8030965-2023-15785
• Device Sequence Number: 6740331
• Product Code: HTO
• UDI-Device Identifier: 10886982291844
• UDI-Public: (01)10886982291844
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: 03.233.010S
• Device Lot Number: 4112P62
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2023
• Initial Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown