MAUDE Adverse Event Report: DEPUY SPINE INC EXPEDIUM SPINE SYSTEM COMPRESSOR, PARALLEL ACTION; PROBE

Catalog Number	279702070
Medical Device Problem Codes	Break (1069); Illegible Information (4050)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
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: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E1: initial reporter phone was reported as +45(407)96949 e3: initial reporter is a distributor.H3, h4, h6: 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.If additional information is made available, the investigation will be updated as applicable.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 denmark as follows: it was reported that during surgery on (b)(6) 2023, the tip of the instrument was broken during compression.There was no patient consequence.The surgery was performed as planned with another instrument.This report involves one expedium spine system compressor, parallel action.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: d4, h4.A review of the receiving inspection (ri) for xpdm compressor, parallel was conducted identifying that lot number e0507 released in nine batches.Batch1: lot qty of (b)(4) units were released 13 jun 2007 with no discrepancies.Batch2: lot qty of (b)(4) units were released 13 jun 2007 with no discrepancies.Batch3: lot qty of (b)(4) units were released 02 jul 2007 with no discrepancies.Batch4: lot qty of (b)(4) units were released 16 jul 2007 with no discrepancies.Batch5: lot qty of (b)(4) units were released 13 sep 2007 with no discrepancies.Batch6: lot qty of(b)(4) units were released 13 sep 2007 with no discrepancies.Batch7: lot qty of (b)(4) units were released 13 sep 2007 with no discrepancies.Batch8: lot qty of (b)(4) units were released 27 sep 2007 with no discrepancies.Batch9: lot qty of (b)(4) units were released 27 sep 2007 with no discrepancies.Supplier: (b)(4).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.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned device does not found that the xpdm compressor, parallel has the etch faded, however the sample was broken from the subcomponent.The broken fragment was returned for evaluation.No other issues were observed.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.The overall complaint was confirmed as the observed condition of the xpdm compressor, parallel 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.¿ as part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: EXPEDIUM SPINE SYSTEM COMPRESSOR, PARALLEL ACTION
• Common Device Name: PROBE
• 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: 18216556
• Report Number: 1526439-2023-02430
• Device Sequence Number: 17543392
• Product Code: HXB
• UDI-Device Identifier: 10705034198460
• UDI-Public: (01)10705034198460
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• 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 Catalogue Number: 279702070
• Device Lot Number: E0507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 01/02/2024
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2007
• 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