MAUDE Adverse Event Report: SYNTHES GMBH 2.5 REAMING ROD BALL TIP/950-STERILE; REAMER

Model Number	351.706S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2023, the scrub tech attempted to add bend into the ball tip guide wire, which then had ball tip guide wire snap near the ball end of the wire.As the new wire was opened, we once again added a bend to the wire, the scrub tech stated that he could feel the new wire also wanting to snap.There was a surgical delay of five (5) minutes.The action was taken as opened another ball tip guide wire.The procedure was completed successfully.There was no fragments were generated.The fragments were removed easily without additional intervention.There was no patient consequences.This complaint involves one (1) device.This report is for one (1) 2.5 reaming rod ball tip/950-sterile.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3/h6: device history lot manufacturing location: supplier ¿ eptam precision metals / inspected, packaged and released by: monument.Release to warehouse date: 17-feb-2023, expiration date: 31-jan-2032, part number: 351.706s, 2.5mm reaming rod with ball tip/950mm - sterile, lot number: 2961p67 (sterile) , lot quantity: 150.Production order traveler met all inspection acceptance criteria.Inspection certificate met all inspection acceptance criteria.Certificate of conformance supplied by eptam dated 10-jan-2023 was reviewed and determined to be conforming.Tensile strength specified as minimum 2000.Certified at 2225-2314.Tensile strength of ball tip specified at minimum of 1023.Certified at 1276-1350.Certifications of heat treat supplied by temperature processing to eptam dated 07-dec-2022 and 09-dec-2022 were reviewed and determined to be conforming.Packaging label log (pll) lppf rev g, lmd rev c was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified supplied by jabil (abq) was reviewed and determined to be conforming.This lot met all dimensional, visual 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.Device history review 25-may-2023: dhr reviewed.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 the product that would contribute to this complaint condition.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: 2.5 REAMING ROD BALL TIP/950-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: 17059984
• Report Number: 8030965-2023-07086
• Device Sequence Number: 20976793
• Product Code: HTO
• UDI-Device Identifier: 10886982193858
• UDI-Public: (01)10886982193858
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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 Model Number: 351.706S
• Device Catalogue Number: 351.706S
• Device Lot Number: 2961P67
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female