MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH REMOBILIZATION TOOL F/LOTUS+USS-II-POLYA; MISC ORTHO SURGICAL INSTR

Catalog Number	03.603.108
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2019
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 the (b)(6) as follows: it was reported on (b)(6) 2019 during an unknown surgery that dr liantis was revising uss poly and needed to mobilize the heads.The device seized up with the t handle unable to turn.As the heads could not be mobilized, they were reliant on the poly heads being locked in a mono position to remove the screws.Concomitant device reported: unknown: screw - uss ii (part# unknown, lot# unknown, quantity# unknown); unknown: screwdriver - uss ii (part# unknown, lot# unknown, quantity# 1).This complaint involves one (1) device.This is 1 of 1 for report (b)(4).
Additional Manufacturer Narrative
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.
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.The visual inspection of the returned remobilization tool has shown no obvious damages.The complaint part was returned with a spring which was inside the instrument.During investigation it was found that this spring does not belong to this part.After the spring was removed from the instrument a functional test was performed, and the part does function without any problems.Therefor the reported problem was not able to be replicated.This instrument was manufactured in september 2017 according to the specification.There were no issues during the manufacturing of the product that would contribute to this complaint condition.A functional test was performed and has shown that the part does function without any problems there for the reported problem was not able to be replicated.As the part does function as intended and as an additional spring was assembled to the part we have to assume that a miss assembling possibly after sterilization procedure has led to the complaint.The root cause was identified during the performed cq evaluation and therefore the in the investigation flow listed remaining investigation steps are not required.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Device history lot.Part: 03.603.108.Lot: l547987.Manufacturing site: haegendorf.Release to warehouse date: (b)(6) 2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.
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.Investigation site: cq zuchwil.Selected flow: device interaction/functional.Visual inspection: the visual inspection of the returned remobilization tool has shown no obvious damages.The complaint part was returned with a spring which was inside the instrument.During investigation it was found that this spring does not belong to this part.Functional test: after the spring was removed from the instrument a functional test was performed, and the part does function without any problems.Therefor the reported problem was not able to be replicated.Summary: this instrument was manufactured in september 2017 according to the specification.There were no issues during the manufacturing of the product that would contribute to this complaint condition.A functional test was performed and has shown that the part does function without any problems there for the reported problem was not able to be replicated.As the part does function as intended and as an additional spring was assembled to the part we have to assume that a miss assembling possibly after sterilization procedure has led to the complaint.The root cause was identified during the performed cq evaluation and therefore the in the investigation flow listed remaining investigation steps are not required.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Device history lot.Part: 03.603.108.Lot: l547987.Manufacturing site: haegendorf.Release to warehouse date: sep 25, 2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: REMOBILIZATION TOOL F/LOTUS+USS-II-POLYA
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9268175
• Report Number: 8030965-2019-69913
• Device Sequence Number: 19366092
• Product Code: LXH
• UDI-Device Identifier: 07611819896116
• UDI-Public: (01)07611819896116
• Combination Product (Y/N): N
• 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,Followup,Followup
• Report Date (Section B): 10/16/2019

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: 03.603.108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 11/06/2019; 12/04/2019; 12/04/2019
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 11/28/2019; 12/24/2019; 12/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1