MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SYNFIX EVOLUTION AWL/WITHOUT SLEEVE

Catalog Number 03.835.032

Device Problem Dull, Blunt (2407)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2020

Event Type  malfunction  

Manufacturer Narrative

Additional 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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that during a procedure on (b)(6) 2020, a synfix® evolution awl/without sleeve was noted to be blunt.The surgeon was unsuccessful in using the synfix® evolution awl/without sleeve.There was a surgical delay of three (3) hours.The procedure was successfully completed.There was no patient consequence.Concomitant device reported: unk - screws: trauma (part # unknown, lot # unknown, quantity unknown).This complaint involves two (2) devices.This report is for one (1) synfix® evolution awl/without sleeve.This is report 1 of 2 for (b)(4).

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, h6: as can be seen from the photographs the tipps of both 03.835.032 synfix evol awls are worn and blunt.Lot i/d¿s are 2 x l479219.After a visual inspection per guidance, it is determined that the reusable instrument is worn from repeated use and service; therefore, further investigation for the reported complaint device is not required.During the investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventative action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market surveillance activities.Both instruments will be disposed of.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 Description

Updated event description it was reported that during an anterior lumbar interbody fusion procedure on (b)(6) 2020, a synfix® evolution awl/without sleeve was noted to be blunt.The surgeon attempted to use a second synfix® evolution awl/without sleeve that was observed to be blunt.The surgeon was unsuccessful in using the synfix® evolution awl/without sleeve.There was no surgical delay.The procedure was successfully completed.There was no patient consequence reported.Concomitant device reported: unk - screws: trauma (part # unknown, lot # unknown, quantity unknown).This report is for one (1) synfix® evolution awl/without sleeve.This is report 1 of 2 for (b)(4).

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.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.

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.Complaint is confirmed as we are able to confirm complaint description (dull tip) based on the received pictures.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 AWL/WITHOUT SLEEVE
• Type of Device: AWL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10063499
• MDR Text Key: 191264569
• Report Number: 8030965-2020-03551
• Device Sequence Number: 1
• Product Code: HWJ
• UDI-Device Identifier: 07612334054371
• UDI-Public: (01)07612334054371
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/04/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 03.835.032
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/04/2020
• Initial Date FDA Received: 05/15/2020
• Supplement Dates Manufacturer Received: 05/18/2020; 06/04/2020; 07/03/2020
• Supplement Dates FDA Received: 05/18/2020; 06/05/2020; 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SYNFIX EVOL AWL; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA