MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L100 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.027.055S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

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 is not distributed in the united states but is similar to device marketed in the usa.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 a patient had surgery on (b)(6) 2018, in (b)(6).The reduction and vertical line of a broken femur were within the standard range, and the postoperative condition was good (due to the protection of patient privacy in the hospital, it is not possible to provide postoperative x-rays ); the patient was discharged from the hospital for physical therapy.After he returned home it was discovered that the bone block was displaced.The doctor confirmed that the event was not related to product quality and/or surgical procedures and had communicated this to the patient.At the same time, the doctor contacted the patient to ask him to return to the hospital for the relevant referral surgery can be continued.The patient said that he is planning to stay in his country for treatment.This is report 1 of 1 for (b)(4).

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.D4: expire date provided for reporting.H3, h4, h6: a review of the device history record.Lot / part: 04.027.055s, lot: l355810, manufacturing site: bettlach, release to warehouse date: 28.Mar.2017, expiry date: 01.Mar.2027.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified h3, h6: investigation summary the complained pictures were forwarded to the medical safety officer for evaluation.Here the statement.This is a reverse oblique intertrochanteric fracture, ao 31a3.3.It is one of the worst we have to deal with.The fracture appears to be fixed with a pfna ii unknown implant.The fracture is malreduced in about 35 degrees of varus.Provided medical record documents reveal that the index procedure was performed on (b)(6) 2018.The ct scan report is reviewed in the clinic visit 18 months later, (b)(6) 2019.It was read as a nonunion in the report (not provided) and revision surgery was made a possibility.Indeed if the fracture was ununited at 18 months it meets the criteria for an established nonunion.The implant is able to manage the load before the nail, can only be provided externally via a medical information request.Provided the ct scan read is correct and there is a nonunion, implant failure is likely imminent meaning months, not years, this fracture could be healed considering how well the patient is doing or if ununited, dynamization could influence late union.Product was not returned.Based on the information available, it has been determined that no corrective and preventive 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.

• Brand Name: PFNA-II BLADE L100 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9530319
• MDR Text Key: 188995223
• Report Number: 8030965-2019-71533
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819394247
• UDI-Public: (01)07611819394247
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.055S
• Device Lot Number: L355810
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/31/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention