MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH NARROW POSTERIOR TAMP, 25MM

Model Number	279755602
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.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
The surgeon was using the vertebral body tamp from the expedium osteotomy set as it was intended.He was malleting on the back of the instrument while the footed tamp was snuggle placed in between the spinal cord and posterior wall of the l4 vertebral body.While malleting, the footed portion to the 25mm tamp broke insitu.Fortunately, the patient was not harmed during this failure and the broken instrument fragment was recovered.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination of the returned device found the longer side of the tamp¿s ¿foot¿ had been broken off approximately halfway down the length of this section of the tip.The distal end of the tip that broke off was not returned.Fracture analysis was subsequently performed on the broken device.Optical imaging of the fractured surface of the device reveals a rough surface.This indicates a single, sharp, heavy load being placed on the tip.Rust is present over the breakage area, but appears to be surface level and may be a result of the fracture plane being outside the passivation layer.No material defects of other abnormalities were observed in this analysis.A supplemental hardness test was performed on the tamp and was found to be within specification.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.The root cause of the foot of the instrument breaking cannot be determined from the sample and the information provided.The results of fracture analysis have determined that a probable root cause is static overload failure due to a single, sudden, unexpectedly high force placed on the tip.It has been noted that the hardness of the material of the instrument at its distal tip was within designed specifications.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: NARROW POSTERIOR TAMP, 25MM
• Common Device Name: TAMP
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8607492
• Report Number: 1526439-2019-51636
• Device Sequence Number: 2372444
• Product Code: HXG
• UDI-Device Identifier: 10705034472829
• UDI-Public: (01)10705034472829
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2019

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: 279755602
• Device Catalogue Number: 279755602
• Device Lot Number: GB73391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR