MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNIVERSAL ALIF INSTRUMENT SET OSTEOTOME, STRAIGHT 15MM

Model Number	273508115
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: event occurred on an unknown date in 2021.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.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.
Event or Problem Description
It was reported that on an unknown date, the surgeon was doing an anterior lumbar interbody fusion (alif) due to an unknown reason.While hitting the instrument with a mallet as its intended purpose the alif osteotome straight 15mm broke.There were no fragments generated.There was no surgical delay.The procedure was successfully completed.There was no patient consequence.This report is for one (1) universal alif instrument set osteotome, straight 15mm.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: h6: photo investigation: the device was not returned for investigation and the investigation was completed on the received image.The picture shows the handle of the osteotome straight.The distal end of the osteotome had broken off and the broken piece was not pictured.Manufacturing record evaluation could not be performed as no lot number was provided.Hence, the current revision of drawing was reviewed.Since the device was not returned, an as-received condition and dimensional inspection could not be reviewed.Conclusion: the complaint condition can be confirmed based on the available information.This might have been due to excessive pressure applied during procedure but a definitive assignable root cause was not identified from the available information.During the investigation, no product design issues, or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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: UNIVERSAL ALIF INSTRUMENT SET OSTEOTOME, STRAIGHT 15MM
• Common Device Name: OSTEOTOME
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 13114757
• Report Number: 1526439-2021-02674
• Device Sequence Number: 17254826
• Product Code: HWM
• UDI-Device Identifier: 10705034190297
• UDI-Public: 10705034190297
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial,Followup

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: 273508115
• Device Catalogue Number: 273508115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2022
• Supplement Date Received by Manufacturer: 01/22/2022
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 01/24/2022
• 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: UNKNOWN IMPACTION INSTRUMENTS
• Patient Sex: Unknown