MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SINGLE INNIE INSERTER; DRIVER, PROSTHESIS

Model Number	279702000
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.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 (b)(6) as follows: it was reported that during a procedure on (b)(6) 2021, the hex was disinserted of the shank during nut tightening.There was no patient harm.Surgery was completed without any inconvenience.This report is for one (1) expedium spine system single inner inserter 5.5.This is report 1 of 1 for complaint (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.H3, h6: a product investigation was conducted.Visual inspection: the complaint device single innie inserter (product code: 279702000, lot number: gm4056101) was returned to cq west chester for investigation.During visual inspection, the tip of the driver was found stripped and the item showed wear consistent with usage of the device.Functional test: a functional test could not be performed as the device was not returned with a mating device.The complaint cannot be replicated as a functional test was not performed.Dimensional inspection: a dimensional inspection was not performed as this is found to be a post manufacturing issue.Document/specification review: based on the date of manufacture, the current and manufactured version of drawing were reviewed.Complaint confirmed: the complaint condition can be confirmed as the driver tip was found stripped which could have led to the difficulty in assembling using the device.Conclusion: the driver tip was damaged which could have caused the issue in assembling during the procedure.Hence, the complaint is being confirmed.A definitive assignable root cause could not be determined from the available information.There was no indication that a design or manufacturing issue contributed to the complaint.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.H6: a review of the receiving inspection (ri) for single innie inserter was conducted identifying that lot number gm4056101 was released in two batches.Batch: lot qty of 9 units were released on (b)(6) 2014 with no discrepancies.Batch: lot qty of 191 units were released on (b)(6) 2014 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 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: SINGLE INNIE INSERTER
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC); 50461 west pontiac trail; wixom MI 48393
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12572924
• Report Number: 1526439-2021-02103
• Device Sequence Number: 19841579
• Product Code: HWR
• UDI-Device Identifier: 10705034198408
• UDI-Public: (01)10705034198408
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2021

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: 279702000
• Device Catalogue Number: 279702000
• Device Lot Number: GM4056101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/07/2021
• Supplement Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN NUT
• Patient Sex: Unknown