MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SAGITTAL IN-SITU BENDER, RIGHT

Model Number	299704200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The 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
During an ais correction with expedium verse dr.(b)(6) performed some in-situ bending of the cocr rods after they were fully seated in the screws and all set screws were final tightened.During the bending of the second rod the in-situ bender brock.No patient harm occurred and the procedure could be completed by using the other side of the rod bender.In addition, during the screw loading on the screw driver, it disassembled itself.The screw driver shaft unlocked itself from the outer sleeve when loading the screw.Specifically the screw driver shaft got pushed out of the sleeve distally during the last turns of loading the screw.The nurse was able to re-create the disassembly by just pulling and simultaneously rotating the screw driver shaft in the sleeve.It seems the retaining mechanism of the outer sleeve is damaged / worn.To complete insertion of the screws we just used the 2nd screw driver from the set.If other, describe: revision surgery of previous ais correction with expedium difar due to progressing lumbar curve below the initial construct., was surgery delayed due to the reported event?: no, action taken when event occurred?: used the other side of the instrument, was procedure successfully completed?: yes, were fragments generated?: yes, if yes, were they removed easily without additional intervention?: yes, patient status/ outcome / consequences: no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: no, is the patient part of a clinical study: no.Concomitant device reported: unknown rod (part#: unknown, lot#: unknown, quantity: 1), unknown screw (part#: unknown, lot#: unknown, quantity: unknown).This complaint involves three (3) device.
Additional Manufacturer Narrative
Product complaint # (b)(4).Udi: (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.Visual examination of the device revealed that the fracture was located at the mouth of the device.The second half of the bender¿s tip was not returned.Fracture analysis was subsequently performed on the broken device.Optical imaging of the fractured surface of the device reveals a rough/uniform surface.This indicates a single, sharp, heavy load being placed on the distal end of bender.No material defects of other abnormalities were observed in this analysis.The static overloading led to a fracture of the mouth of the device.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.A definitive root cause for the mouth of the sagittal in-situ bender fracturing cannot be positively determined.However, the fracture analysis report notes that a probable root cause is static overload failure due to a single, sudden, unexpectedly high force placed on the bender.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: SAGITTAL IN-SITU BENDER, RIGHT
• Common Device Name: BENDER
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9174478
• Report Number: 1526439-2019-52231
• Device Sequence Number: 11673280
• Product Code: HXW
• UDI-Device Identifier: 10705034467337
• UDI-Public: (01)10705034467337
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 299704200
• Device Catalogue Number: 299704200
• Device Lot Number: GB103407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 12/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 17 YR