MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER2 SCREW EXTENSION, CLOSED; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	286725200
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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, during an mis procedure on a patient with th9 fracture, three (3) of the screw extension instruments detached from the screws.The surgeon was unsuccessful in attaching the extension on the screws while they were still implanted in the patient.The affected screws were explanted.The extensions were then re-attached, the screws re-implanted, and the procedure was successfully completed.There was a surgical delay of sixty (60) minutes.There was no patient consequence.Concomitant device reported: unknown screw (part# unknown, lot# unknown, quantity unknown); unknown rods (part# unknown, lot# unknown, quantity unknown).This report is for one (1) viper2 screw extension, closed.This is report 1 of 6 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.Visual inspection: the viper2 screw extensions, closed (p/n: 286725200, lot #: mi32949) were returned (qty: 10) and received at us cq.It is not clear which is the alleged device among the returned devices, therefore all the devices were inspected.Upon visual inspection, scratches were observed on the device but have no impact on the functionality of the devices.The distal tips of the device were inspected, and no issues were identified.Functional test:the functional test was performed on the returned viper2 screw extensions, closed (p/n: 286725200, lot #: mi32949, qty: 10) devices using mis ti cfx fen poly 6x55 (product code: 1867-27-655, lot number: avcbky).The polyaxial head of mis ti cfx fen poly 6x55 (product code: 1867-27-655, lot number: avcbky) is identical to the polyaxial head of viper uni screw 5x30mm ti (product code: 1867-20-530).Therefore, mis ti cfx fen poly 6x55 (product code: 1867-27-655, lot number: avcbky) was used for the functional testing on the 10 returned viper2 screw extensions and there was no discrepancy observed in the functioning of the devices.Investigation conclusion: the complaint condition was unconfirmed for the viper2 screw extension, closed (p/n: 286725200, lot #: mi32949).There is no indication that a design or manufacturing issue has caused the issue 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.H3, h4, h6: a device history record (dhr) review was conducted: a review of the receiving inspection (ri) for viper2 screw extension, closed was conducted identifying that lot number mi32949 was released in a single batch.Batch1: lot qty of 56 units were released on 18 feb 2015 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: VIPER2 SCREW EXTENSION, CLOSED
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10474522
• Report Number: 1526439-2020-01575
• Device Sequence Number: 3085674
• Product Code: LXH
• UDI-Device Identifier: 10705034214313
• UDI-Public: (01)10705034214313
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2020

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: 286725200
• Device Catalogue Number: 286725200
• Device Lot Number: MI32949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 10/05/2020
• 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: UNKNOWN RODS; UNKNOWN SCREWS