MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH INSERT-HANDLE F/ETN F/SUPRAPATELLAR APPR; NAIL, FIXATION, BONE

Model Number 03.010.440

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2019

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is company representative.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 on an (b)(6) 2019, during a suprapatelar tns surgery, doctor reported a bad experience in the handling of instruments where a connection piece was damaged.After initiating the surgical procedure, the nail to be placed is mounted, the medullary canal is rhymed, the nail is inserted over the protection sheath and additionally the connection piece for the insertion arch is screwed.It is hammered on it to introduce the nail which, upon impact, started leaving the nail in the middle.The specialist followed the impact directly on the insertion arch on a compress, finishing the complete insertion of the nail, the specialist proceeded to perform the distal block.Under radiographic control, as the specialist observed the fracture focus which is diastasized with a wide gaf, it was retro impacted to reduce the fracture, as the connection piece was damaged.Doctor concluded that the best option is to hit directly with several compresses on the insertion arch, resulting in the damage of the same, then the proximal freehand block was performed.Specialist assessed that this is only way to reach the complete reduction of the fracture otherwise the results would not be favorable for the patient and at the time it was important.Concomitant devices reported: unknown hammer (part# unknown, lot# unknown, quantity# 1), unknown tibial nail (part# unknown, lot# unknown, quantity# 1).This complaint involves three (3) devices.This report is for one (1) insert-handle f/etn f/suprapatellar appr.This is report 2 of 3 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.H11: corrected data: g4: awareness date reported on follow up 1 report as november 13, 2019 but should have been december 05, 2019.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 device reported: unknown hammer (part# unknown, lot# unknown, quantity# 1).

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.

• Brand Name: INSERT-HANDLE F/ETN F/SUPRAPATELLAR APPR
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9307989
• MDR Text Key: 191083204
• Report Number: 8030965-2019-70207
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 10886982068828
• UDI-Public: (01)10886982068828
• Combination Product (y/n): N
• PMA/PMN Number: K111667
• 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: 10/24/2019

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 Model Number: 03.010.440
• Device Catalogue Number: 03.010.440
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 11/12/2019
• Supplement Dates Manufacturer Received: 11/13/2019; 01/02/2020
• Supplement Dates FDA Received: 01/01/2020; 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA; UNK - NAILS: EXPERT TIBIAL