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

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown nails: pfna/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 that on an unknown date that a patient¿s nail broke approximately ten (10) weeks after implantation.An x-ray, taken on an unknown date, shows that the locking bolt appears worn.It was unknown if the device was explanted.Patient outcome was unknown.Concomitant devices reported: nail head elements: pfna blade (part number unknown, lot unknown, quantity 1), cerclage wire (part number unknown, lot unknown, quantity 1), end cap: pfna (part number unknown, lot unknown, quantity 1).This report involves unknown nails: pfna.This is report 1 of 1 for (b)(4).

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: reviewing the provided picture, the complaint description can be confirmed that distal the pfna nail is broken off.Statement of the position of the locking bolt: the oblong distal locking hole in short femoral nails was first used in the tfn.The intent of the slot is that the natural variation in nail bend makes it impractical to design a fixed aiming arm to target the hole without significant chance of drilling into the nail shaft/ missing the hole in.If the screw is angled at a high enough angle, it will affect a static lock as the screw shaft will contact the superior and distal end of the slot (as shown in the technique guide).The screw from the x-rays is not quite bearing against the slot in the nail but nearly so.The amount of motion would be less than ½ the diameter of the screw shaft.There is not enough potential motion.The locking screws for nails (excepting some few systems like the proximal humeral nail) do not rigidly lock like the va or sl screws.The screw depicted in the x-ray is in the statically locked position.The wear traces on the screw is probably due to the lateral contact between the nail and the locking bold.Product was not returned.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.

• Brand Name: UNK - NAILS: PFNA
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10478019
• MDR Text Key: 205342490
• Report Number: 8030965-2020-06516
• 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: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2020
• Patient Sequence Number: 1
• Treatment: UNK - CABLE/WIRE: ORTHOPAEDIC CABLE; UNK - END CAPS: PFNA; UNK - NAIL HEAD ELEMENTS: PFNA BLADE; UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR