MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SYNFIX EVOLUTION AIMING . DEVICE HOLDER; IMPACTOR

Catalog Number	03.835.004
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/25/2020
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.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the synfix evolution aiming device holder was faulty not able to retract and hold an unknown aiming device.Another device was used.There was a fifteen (15) minutes surgical delay.Procedure was successfully completed.There was no patient consequence.Concomitant device reported: unknown aiming device (part# unknown, lot# unknown, quantity 1).This complaint involves one (1) device.This report is for (1) synfix® evolution aiming device holder.This is report 1 of 1 (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.H3, h4, h6- the device was returned in assembled condition.In general is the device is a good condition, there are no visible damages, just some slight wear marks for example at the sliding surface at the forefront of the inner sleeve in the area of the balls.The device is slightly rough-running.All features related to the reported complaint condition were reviewed and no other issues were identified.It was not possible to replicate the complained jamming and the device was functional during the performed function test, therefore this complaint is rated as unconfirmed.In general the importance of lubrication as defined in the dai of this instrument can be pointed out.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition 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.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot part number: 03.835.004, synthes lot number: 9814728, manufacturing site: hägendorf, release to warehouse date: 09.Feb.2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances related to the malfunction were identified.However, non conformance nr-0039401 and nr-0041060 were found during dhr review.These non conformance's are not related to the reported complaint condition and are referable to an burr issue.All parts were reworked and were checked to 100% before left the manufacturing site.,part number: 03.835.004, synthes lot number: 9814728, manufacturing site: hägendorf, release to warehouse date: 09.Feb.2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances related to the malfunction were identified.However, non conformance nr-0039401 and nr-0041060 were found during dhr review.These non conformance's are not related to the reported complaint condition and are referable to an burr issue.All parts were reworked and were checked to 100% before left the manufacturing site.Dhr review was already conducted.Hence no further dhr review necessary.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d10, h3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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: SYNFIX EVOLUTION AIMING . DEVICE HOLDER
• Common Device Name: IMPACTOR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10554604
• Report Number: 8030965-2020-07202
• Device Sequence Number: 3581351
• Product Code: HWA
• UDI-Device Identifier: 07611819677043
• UDI-Public: (01)07611819677043
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 08/24/2020

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 Catalogue Number: 03.835.004
• Device Lot Number: 9814728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 10/01/2020; 11/03/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 10/21/2020; 11/03/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - GUIDES/SLEEVES/AIMING: SPINE; UNK - GUIDES/SLEEVES/AIMING: SPINE