MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH SHORTCUT PLATE CUTTER FOR 2.4MM PLATES & THORP; INSTRUMENT,CUTTING,ORTHOPAEDIC

Catalog Number 391.967

Device Problem Contamination /Decontamination Problem (2895)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: 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.(b)(4).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) 2018, there was a contamination issue with the shortcut plate cutter for 2.4mm plates & thorp used during an unknown surgical procedure.It was reported that the shortcut plate cutter handle material caused contamination of the surgery which the hospital is holding remote patient monitoring (rpm) distributor accountable.The brackets were sterilized in degree and it was then observed that the degree had spots after the sterilization process.The hospital claims the issue is due to the wood handle and the quality of the keys used.The device was still used for the surgical procedure, and the patient then presented with infection after the surgery was completed.It also prohibited the entrance and use of other instruments made with the same material as the shortcut plate cutter.The hospital needs to support rpm with technical and regulatory arguments establishing the security and authorization for use of these tools.Surgical delay is unknown.Patient and surgical outcome are unknown.This report is for one (1) shortcut plate cutter for 2.4mm plates & thorp.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Updated event description: device was used for treatment, not diagnosis.

Event Description

11/25/2018: updated event description: it was reported that the remote patient monitoring (rpm) is having difficulty due to a surgery performed on (b)(6) 2018.This surgery involved a box of unilock 2.4 that has a shortcut/thorp with a handle of a material that the hospital says is not permitted to be used for surgical instruments.It was also reported that there was contamination of the surgery that may have caused the infection.It is unknown if there was any surgical delayed.Patient and surgical outcome was unknown.This complaint involves one (1) device.

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.Device is not expected to be returned for manufacturer review/investigation.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: SHORTCUT PLATE CUTTER FOR 2.4MM PLATES & THORP
• Type of Device: INSTRUMENT,CUTTING,ORTHOPAEDIC
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7951421
• MDR Text Key: 123220209
• Report Number: 8030965-2018-57150
• Device Sequence Number: 1
• Product Code: HTZ
• 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
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 391.967
• Device Lot Number: (01)10887587041056
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention