MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L85 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.027.052S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 05/23/2018

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown.Device malfunctioned intra-operatively and was not implanted / explanted.Reporter email address is unavailable.Device is not distributed in the united states, but is similar to device marketed in the usa.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A device history records review has been requested.(b)(4) used to capture surgical intervention and surgical delay of less than thirty (30) minutes.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 europe reports an event in (b)(6) as follows: on (b)(6) 2018, open reduction internal fixation (orif) surgery for a femoral neck fracture was performed using the proximal femoral nail antirotation (pfna) system.During surgery, it was found that the helical blade was inserted but could not be locked.The surgeon extracted the blade by using the extraction screw to replace it with a smaller sized blade.After the surgery, the surgeon noticed that the original helical blade could not be detached from the extraction screw.The surgery was completed successfully with a less-than-30-minute delay.There was no adverse consequence to the patient.This report is for a pfna-ii blade l85 tan.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Patient ethnicity is unknown.Part: 04.027.052s; lot: l745600; manufacturing site: (b)(4); release to warehouse date: january 29, 2018, expiry date: january 01, 2028; the device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Investigation site: (b)(6); selected flow(s): 2.Device interaction/functional visual inspection: the blade is completely blocked with the extraction screw.It is impossible to disassemble the blade from the screw.The tip of the blade is badly deformed and shows strong signs of contact with the nail during insertion.This is clear indication that the blade got damaged during insertion.This may happen when the blade is not correctly aligned with the nail.The blade in question is in complete unlocked position and can be turned freely.The locking mechanism is damaged and is not able to be locked / unlocked.The system is completely destructed.Functional test: as result of the damages, no functional test is possible.The mechanism of locking / unlocking is destructed and the blade is not possible to release from the extraction screw.As the blade is in unlocked position, the complaint is classified as confirmed.It is not possible to lock the system as complained.As result to the damages and as the blade is blocked on the screw, no dimensional- or functional tests are possible.Design and clinical risk management (dcrm) was reviewed and found to adequately address the harm of this complaint condition.The complaint is adequately addressed by the risk assessment.As result of our investigations, use error while insertion is most probably root cause the reported problem.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 L85 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7611605
• MDR Text Key: 111432418
• Report Number: 8030965-2018-54406
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819394216
• UDI-Public: (01)07611819394216
• 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
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.052S
• Device Lot Number: L745600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 06/18/2018
• Supplement Dates Manufacturer Received: 06/25/2018
• Supplement Dates FDA Received: 07/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention