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

Catalog Number	299704195
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that patient underwent an unknown procedure on an unknown date in 2024.During the procedure, the sagittarius bender end was broken.There was no surgical delay.There was no patient consequence.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by (b)(4), or its employees that the report constitutes an admission that the product, (b)(4), or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.E1: facility name - (b)(6) medical center on behalf of (b)(6) center.
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.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
Additional information received states that no fragments were generated.
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.H11 additional narrative: added; d4 (expiry date, lot) d9.Corrected: d4 (primary udi number).H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.H11 additional narrative: added: h4.H3, h4, h6: physical device investigation.The product was returned to j&j medtech orthopaedics for evaluation.The j&j medtech orthopaedics team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the sagittal in-situ bender, left was broken in the distal section of the device, the remaining pieces were not returned for evaluation.The overall aspect of the device shows signs of normal use of service.A dimensional inspection was not performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the sagittal in-situ bender, left would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.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.Photo investigation: the product was not returned to medtech orthopedics; however, photos were provided for review.The photo investigation revealed that '299704195, sagittal in-situ bender, left has broken at one end.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the sagittal in-situ bender, left would contribute to the complained device issue.Based on the investigation findings, the bender has broken because of unintended force, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of medtech orthopedics quality process, all devices are manufactured, inspected, and released to approved specifications.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 of sagittal in-situ bender, left was conducted identifying that lot number gb144657 released in one batches.Supplier : (b)(4).Batch1: lot qty of (b)(4).Units were released on 06 dec 2022 with no discrepancies.Device history review: 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.If information is obtained that was not available for the initial report, a follow-up report 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 Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 21072356
• Report Number: 1526439-2025-00007
• Device Sequence Number: 20932495
• Product Code: HXW
• UDI-Device Identifier: 10705034467320
• UDI-Public: (01)10705034467320(10)GB144657
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,Followup,Followup,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 Catalogue Number: 299704195
• Device Lot Number: GB144657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 01/06/2025; 01/22/2025; 01/30/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 01/09/2025; 01/23/2025; 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2022
• 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
• Patient Sex: Unknown