MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH ROD CUTTER; CUTTER,WIRE

Catalog Number 388.72

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/29/2020

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6), 2020, during a posterior lumbar fixation procedure the rod cutter was broken when the surgeon was cutting the rod during surgery and some small pieces of metal broke off.The procedure was successfully completed.There was a surgical delay of twenty (20) minutes.There was no patient consequence.Concomitant device reported: rod (part# 63-lt-5110, lot# unknown, quantity# 1).This report is for one (1) rod cutter.This is report 1 of 1 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.

Event Description

It was noted that the rod being cut was a titanium rod and not a cobalt chromium rod as originally thought.

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.Visual inspection: the complaint condition is confirmed, there are two (one small / one large) round (rod) shaped pieces broke out at both cutting edges of the bolt cutter.Otherwise is the device in a good condition.Drawing/specification review: the manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.The investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device.Please refer the surgical techniques matrix spine system ¿ degenerative (dsem-spn-0115-0266-2_lr) in this is noted; the uss rod cutting and bending device must be used to cut cobalt chromium rods (art.388.750).Summary: the received condition agree with the complaint description and the complaint therefore is confirmed.We assume that the damage of the cutting edges is occur while an cobalt chrome rod was cut, which is confirmed by the rod shaped fracture face that is typical when a extra hard cobalt chrome rod is cut with the bolt cutter 388.720.In this relation the corresponding surgical techniques must be mentioned with the clear statement that the uss rod cutting and bending device (388.750) must be used to cut cobalt chromium rods.Based on that it can be concluded that use error, by not following the surgical technique, caused the complained malfunction.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.The root cause was identified during the performed cq evaluation and therefore the in the investigation flow listed remaining investigation steps "dimensional inspection:" 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.The attached picture of investigation is saved by the voided complaint number (note: voided because it was created under incorrect opco.All event details will be captured under complaint (b)(4).Device history (lot) part number: 388.720, lot number: t139407, manufacturing site: tuttlingen, release to warehouse date: jul 1, 2016.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.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.H3, h4, h6- the complaint condition is confirmed, there are three (3) (two small / one large) round (rod) shaped pieces broke out at both cutting edges of the bolt cutter.Otherwise is the device in a good condition.The received condition agree with the complaint description and the complaint therefore is confirmed.During previous investigations we were able to reproduce the exact same kind of damage by cutting extra cobalt chrome rods.Therefore we came to the conclusion that once such a rod was cut with the device.There are three (3) more or less deep grooves at the cutting edges visible which indicates that there were three attempts made to cut a hard rod and that the cutting edges did get damaged three times in a similar manner.It cannot be excluded that some of the damages occurred during a previous surgery and the device was blunt due to the previous damages.This could have caused a mechanical overload when the mentioned titanium rod was cut.In this relation the corresponding surgical techniques must be mentioned with the clear statement that the uss rod cutting and bending device (388.750) must be used to cut cobalt chromium rods.Based on that it can be concluded that use error, by not following the surgical technique, caused the complained malfunction.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.The root cause was identified during the performed cq evaluation and therefore the in the investigation flow listed remaining investigation steps "dimensional inspection:" 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.The attached picture of investigation is saved by the voided complaint number (note: voided because it was created under incorrect opco.All event details will be captured under complaint (b)(4)).Device history lot : device history (lot) part number: 388.720, lot number: t139407, manufacturing site: tuttlingen, release to warehouse date: 01-jul-2016.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.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: ROD CUTTER
• Type of Device: CUTTER,WIRE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10467436
• MDR Text Key: 212741145
• Report Number: 8030965-2020-06455
• Device Sequence Number: 1
• Product Code: HXZ
• 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,distri
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 388.72
• Device Lot Number: T139407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - RODS