MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA BLADE PERF L90 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.027.033S

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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 a revision surgery occurred on (b)(6) 2020 due to a proximal femoral nail (pfn) screw loosening.The pfn system was implanted approximately two weeks ago on (b)(6) 2020.The patient was revised to total hip prosthesis.Surgical delay and patient status are unknown.Concomitant devices reported: proximal femur nail titan (pfn) (part# l000640, lot# unknown, quantity 1).Unknown hip pin (part# unknown, lot# unknown, quantity 1).Unknown locking bolt (part# unknown, lot# unknown, quantity unknown).This is report 1 of 1 for (b)(4).This report is for an unknown screw.

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.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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

Upon x-ray review it was noted that the pfna blade migrated; not the locking screw as previously reported.Updated concomitant devices reported: pfna nail (part 472.265s, lot 31p1364, quantity 1); end cap (part 04.027.000s, lot 1l09690, quantity 1); locking screw (part 04.005.526s, lot 6l89789, 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.Investigation summary: picture review: narrative (migration of pfna blade) could be confirmed from provided picture.Investigation site: cq zuchwil selected flow: device interaction/functional.Visual inspection: the pfna blade was received in a locked condition.On the sleeve of the pfna blade are slightly wear marks visible.No other visual damage could be observed at the blade.Functional test: the function test at zuchwil customer quality was conducted with a demo impactor with the result that the blade could be locked / unlocked as per design intended.It was possible to attach the blade to the impactor without any issues and the tip of the pfna blade did rotate freely after attaching as required.Also the blade was locked as required after the impactor was removed.Dimensional inspection was performed as below: document/drawing: document/drawing revision feature/test/description: citrus from specification gage 3-01-19788 results "pass" feature/test/description: citrus form specification gage 3-01-19788 results "pass".The measured dimensions were found to be within the given specifications per the drawings referenced above.Document/specification review: the review of the device history record revealed that this implant was manufactured in january 2020.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities noted; visual and functional checked were performed per 100% after the assembly of the component parts.No manufacturing related issues that would have contributed to this complaint were found.Summary: the complaint is confirmed as the attached x-rays could be verified as implant migration.But the complaint is rated as unconfirmed for this pfna blade based that the blade is functional as required.We cannot determine the exact root cause of the complained issue "implant migration".By the x-rays review it seems that the pfna blade is locked as intended.Finally we are based on the provided information we are not able to determine the exact cause of this occurrence.We can only assume that there was a complication during the healing process that caused this problem.Postoperative activities of the patient and a possible instability of the fracture situation (poor bone density) may have played a certain role, too.Since not all of them can be investigated and excluded from the root cause analysis, no final statement about the cause of such issues of pfna blade migration can be made.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: part:04.027.033s , lot:33p2645 , manufacturing site: bettlach, release to warehouse date: january 7, 2020 , expiry date: december 1, 2029.A manufacturing record evaluation was performed for the finished device part: 04.027.033s, lot: 33p2645, and no non-conformances were identified.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 BLADE PERF L90 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10202446
• MDR Text Key: 196954335
• Report Number: 8030965-2020-04498
• Device Sequence Number: 1
• Product Code: HSB
• 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,Followup
• Report Date: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.033S
• Device Lot Number: 33P2645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Date Manufacturer Received: 09/03/2020
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø5 L36 F/NAILS TAN LIGHT GREEN; PFN - PROXIMAL FEMUR NAIL TITAN; PFNA END CAP EXTENS. 0 T40 TAN; PFNA Ø10 130° L240 TAN; UNKNOWN HIP PIN; UNKNOWN LOCKING BOLT
• Patient Outcome(s): Required Intervention