MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.5MM LCP® MEDIAL PROXIMAL TIBIA PLATE 14H/LEFT 286MM; PLATE,FIXATION,BONE

Catalog Number 239.995

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Not Applicable (3189)

Event Date 11/29/2019

Event Type  Injury  

Manufacturer Narrative

Product was not returned.Based on the information available, it has been determined that no corrective and 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.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 product was received; no conclusion could be drawn at the time of filing this report.(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 on an unknown date that the patient was underwent for plate surgery on (b)(6) 2019.On operating time, they noticed that they did not received ordered plate yet.They were going to use only 1 implant for the surgery.They didn¿t know the exact needed size, so they ordered two lengths of the plate to be prepared.The surgeon used alternate products to complete the procedure and the procedure was delayed more than 60 minutes.The patient outcome is unknown.This is report 2 of 4 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.H10 additional narrative: b5: updated event description.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 the customer ordered products 239.995 and 239.997 to customer service on (b)(6) 2019; however these items were on back order, so the customer changed the order to sterile products (239.995s and 239.997s).Customer service was supposed to order these sterile devices and no back order was announced.The surgery with these plates was planned on (b)(6) 2019.After the surgery started it was noticed that the ordered plates haven't received.This has led to the situation that operation has been started and the patient was on the operating table.Consequence was that the surgery has been prolonged for over one (1) hour.Also the missed delivery led to the situation that the patient was not operated with the original plan and originally planned implantation, surgeon had to make alternative decision to treat the patient.This situation was created, because customer service hadn't made the order of the sterile products, when customer had placed the order.Surgeon was planning to use only 1 implant for the surgery, but didn¿t know the exact needed size so he ordered two lengths of the plate to be prepared.

• Brand Name: 4.5MM LCP® MEDIAL PROXIMAL TIBIA PLATE 14H/LEFT 286MM
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9489424
• MDR Text Key: 188092187
• Report Number: 8030965-2019-71203
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819916722
• UDI-Public: (01)07611819916722
• Combination Product (y/n): N
• PMA/PMN Number: K050646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 239.995
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention