MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME ROD HOLDER STEM; MISC ORTHO SURGICAL INSTR

Model Number	286750061
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 on (b)(6) 2020 after attaching and tightening the rod, the instruments seized together.The rod could only be loosened with the application of force.The instruments remained seized.There was no surgery delay reported.There was no patient consequence.The surgery was successfully completed.Concomitant device reported: unknown rods (part #: unknown, lot #: unknown, quantity unknown).This report is for one (1) viper prime rod holder stem.This is report 1 of 3 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.H3, h4, h6: a review of the receiving inspection (ri) for viper prime rod holder stem was conducted identifying that lot number mi72175 was released in a single batch.Batch1: lot qty of (b)(4) were released on 25 jan 2019 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.Visual inspection: the viper prime rod holder stem (p/n: 286750061, lot # mi72175) was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the device was received assemble with the push rod (p/n: 286750063) and the rod holder shaft (p/n: 286750062).There were scratches on the device but have no impact on the device functionality.No other issues were identified with the returned device.Functional test: a functional test was performed on the returned devices.During functional test, the rod holder shaft was noticed to be jammed inside the rod holder stem and was failed to disassemble from the rod holder stem, confirming the complaint condition.There were no issues identified with the push rod as it still actuates but cannot be disassembled from the rod holder stem because of jammed rod holder shaft.Can the complaint be replicated with the returned device? yes.Dimensional inspection: a dimensional inspection was not performed as the internal components were inaccessible without destruction of the device.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.- viper prime rod holder stem assembly.Complaint confirmed? yes, the device received was unable to disassemble.Hence confirming the allegation.Investigation conclusion: the complaint condition is confirmed for the viper prime rod holder stem (p/n: 286750061, lot # mi72175).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 PRIME ROD HOLDER STEM
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10624687
• Report Number: 1526439-2020-01874
• Device Sequence Number: 3232670
• Product Code: LXH
• UDI-Device Identifier: 10705034507675
• UDI-Public: (01)10705034507675
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2020

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: 286750061
• Device Catalogue Number: 286750061
• Device Lot Number: MI72175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 10/04/2020
• Supplement Report FDA Received Date: 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PRIME ROD HOLDER PUSHROD; UNKNOWN RODS; VIPER PRIME ROD HOLDER SHAFT; PRIME ROD HOLDER PUSHROD; UNKNOWN RODS; VIPER PRIME ROD HOLDER SHAFT