MAUDE Adverse Event Report: DEPUY SPINE INC VIPER SYSTEM RATCHETING ADAPTER, CANN.; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	286710490
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from germany reports an event as follows: both ratchet adapters have been reported as defective.One of the two is broken in the middle.In the second case, the ratchet does not work anymore.There was no reported patient involvement.No further information is available.This report is for a viper system ratcheting adapter, cann.This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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: e3: initial reporter is a synthese employee.A review of the receiving inspection (ri) for ratcheting adapter, cannulated was conducted identifying that lot number km894305 released in two batches.¿ batch1: lot qty of (b)(4) units were released on 23 feb 2021 with no discrepancies.¿ batch2: lot qty of (b)(4) units were released on 23 feb 2021 with no discrepancies.Supplier: tecomet.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 synthese for evaluation.The depuy synthese team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the weld of ratcheting adapter, cannulated was broken, causing the parts of the device to fall apart.No other problems were identified.A dimensional inspection for the ratcheting adapter, cannulate was not performed as is not applicable to the complaint condition.A functional test was performed and the adapter would not work as it would fell apart.The complaint condition was able to be replicated.As part of depuy synthese quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the ratcheting adapter, cannulate would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 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: VIPER SYSTEM RATCHETING ADAPTER, CANN.
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 16833383
• Report Number: 1526439-2023-00762
• Device Sequence Number: 15249007
• Product Code: LXH
• UDI-Device Identifier: 10705034213880
• UDI-Public: (01)10705034213880
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial

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: 286710490
• Device Catalogue Number: 286710490
• Device Lot Number: KM894305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2021
• 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