MAUDE Adverse Event Report: SYNTHES GMBH 130 DEG ANGLED BLADE PLATE 12 HOLES/80MM/200MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT

Catalog Number 238.26

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is jnj representative.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.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 reported that on an unknown date, the unknown blade plate was broken after the initial operation was conducted.On (b)(6) 2017, and a new blade plate was inserted.On (b)(6) 2017, the patient had another corrective procedure due to the blade plate breaking again.No further information was provided.This is report 1 of 1 for (b)(4) was created to capture first revision (b)(4) was created to capture second revision.

Manufacturer Narrative

Product complaint # (b)(4).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: h3, h6: the investigation could not be completed, no conclusion could be drawn at the time of filing this report.Product was not returned.The customer is retaining the product.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.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.H6: device history record (dhr) review was unable to be completed due to invalid lot number.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.D7: it is unknown if this single-use device was reprocessed and reused.

Event Description

It was reported that patient underwent revision surgery on (b)(6) 2017 to remove a broken proximal femoral nail antirotation (pfna) blade.Pfna was originally implanted in 2016.The fracture point was then fixated using a new blade plate.On an unknown postoperative date, the broke and patient underwent a second revision surgery on (b)(6) 2017.A new blade plate was implanted.This plate broke on an unknown postoperative date and was removed on (b)(6) 2017.This report is for a 130 deg angled blade plate 12 holes/80mm/200mm.

• Brand Name: 130 DEG ANGLED BLADE PLATE 12 HOLES/80MM/200MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11375405
• MDR Text Key: 242319174
• Report Number: 8030965-2021-01325
• Device Sequence Number: 1
• Product Code: KTW
• Combination Product (y/n): N
• PMA/PMN Number: K914546
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,study
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 238.26
• Device Lot Number: 749
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 130 DEG ANGLED BLADE PLATE 9 HOLES/90MM/154MM; PFNA Ø10 130° L240 SST
• Patient Outcome(s): Required Intervention