MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES: SPINE; PLATE, FIXATION, BONE

Catalog Number UNK - PLATES: SPINE-US

Device Problem Compatibility Problem (2960)

Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)

Event Date 03/02/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).510k: this report is for an unknown plate/unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; 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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that the doctor placed the guide in the hole of the plate and attempted to seat it.He had a little trouble doing this, however managed to seat the pin in the hole of the plate and placed 4 screws.As he lifted the guide out of the last place the pin got stuck and he had to remove the pin with forceps.Surgery was delayed due to the reported event five (5) minutes.Concomitant devices reported: unknown plate (part # unknown, lot # unknown, quantity # 1), unknown screws (part # unknown, lot # unknown, quantity # unknown).This complaint involves one (1) device.This report is 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.G4: date received by manufacture of the initial report should be march 2, 2020.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

This report is 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.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

Concomitant devices reported: screws (part: unknown, lot: unknown, quantity: unknown); drill/tap and screw guide with post (03.613.001, lot number: 3111809, quantity: 1).

• Brand Name: UNK - PLATES: SPINE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9891071
• MDR Text Key: 186533711
• Report Number: 8030965-2020-02353
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• 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: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - PLATES: SPINE-US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2020
• Patient Sequence Number: 1
• Treatment: DRILL+SCRGUIDE F/VECTRA+VECTRA-T; DRILL+SCRGUIDE F/VECTRA+VECTRA-T; DRILL+SCRGUIDE F/VECTRA+VECTRA-T; DRILL+SCRGUIDE F/VECTRA+VECTRA-T; UNK - PLATES: SPINE; UNK - SCREWS; UNK - SCREWS; UNK - SCREWS