MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAILS: PFNA-II; ROD, FIXATION, INTRAMEDULLARY

Device Problem Migration (4003)

Patient Problem Non-union Bone Fracture (2369)

Event Date 02/08/2022

Event Type  Injury  

Manufacturer Narrative

Additional narrative: 510k: this report is for an unknown pfna ii nail/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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 depuy synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent surgery with proximal femoral nail antirotation (pfna) implants.After surgery, on (b)(6) 2022, cut-out was found.On (b)(6) 2022, pfna implants were removed and the bha was performed in the revision surgery.The revision surgery was completed successfully with no surgical delay.No further information is available.This report is for one (1) unknown pfna ii nail.This is report 2 of 4 for complaint (b)(4).

• Brand Name: UNK - NAILS: PFNA-II
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13773067
• MDR Text Key: 287352933
• Report Number: 8030965-2022-01651
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - END CAPS: PFNA-II; UNK - NAIL HEAD ELEMENTS: PFNA-II BLADE; UNK - SCREWS: PFNA-II
• Patient Outcome(s): Required Intervention
• Patient Age: 92 YR
• Patient Sex: Female