MAUDE Adverse Event Report: DEPUY SPINE INC SAGITTAL IN-SITU BENDER, LEFT

Model Number	299704195
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 the patient underwent for a surgery.During the surgery, the in-situ bender¿s discharge pieces are bent.As a result, the operator always slipped off when bending the rod.It was unknown if the surgery completed successfully.There was no patient consequence.Concomitant device reported: unknown rod (part# unknown, lot# unknown, quantity unknown) this complaint involves two (2) devices.This report is for (1) sagittal in-situ bender, left this report is 1 of 2 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.Visual inspection: the complaint device sagittal in-situ bender, left (product code: 299704195, lot number: gb103406) was returned to cq west chester for investigation.The item was slightly bent and had been deformed near the holder portion of the bender.The device had been severely scratched as well.These defects are identified to be end of life indicators for the part according to 0000277191.Hence, no further investigation is needed.Conclusion: the returned part had been worn out due to continued usage.Hence, the cause of this issue is end of life for the part.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a review of the receiving inspection (ri) for sagittal in-situ bender, left was conducted identifying that lot number gb103406 was released in a single batch.Batch1: lot was released on may 23, 2017 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device history review: the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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: SAGITTAL IN-SITU BENDER, LEFT
• Common Device Name: BENDER
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): BRIDGEWATER DISTRIBUTION; 50 scotland boulevard; bridgewater MA 02324
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13171879
• Report Number: 1526439-2022-00022
• Device Sequence Number: 4517874
• Product Code: HXW
• UDI-Device Identifier: 10705034467320
• UDI-Public: (01)10705034467320
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Foreign,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: 299704195
• Device Catalogue Number: 299704195
• Device Lot Number: GB103406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SAGITTAL IN-SITU BENDER, RIGHT; UNKNOWN RODS
• Patient Sex: Unknown