MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PF ANT CUT GUIDE LT; PRSTHSSKNEFMOOTILNNCNSTRINDCMETMTALOLYMR

Model Number 71563410

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 11/13/2019

Event Type  malfunction  

Event Description

It was reported that during surgery, the quick connect trocar pins snapped off when trying to remove it from one of the pin holes on the left anterior cutting guide.The surgeon was using the quick connector on reverse power to reverse the pin out when it snapped.He suspects the possible damage caused to the quick connector earlier may have meant the pin wasn't spinning straight when inserting and removing it.Fortunately the half of the pin that had been in the bone was easily retrieved and the scrub nurse was later able to remove the other half of the pin from the block.No delay.No backup device available.No impact to patient.

Manufacturer Narrative

Additional information has identified that this event should be re-evaluated for mdr reporting.The new information states that the device broke outside the patient and there was no impact or injury, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

Manufacturer Narrative

The associated devices, used in treatment, were returned and evaluated.A visual inspection of the returned devices confirmed the stated failure modes.The fixation holes in the anterior cutting guide were damaged and the pin that mates with those holes was fractured.The drill was stuck in the drill guide.The chuck end of the drill was damaged.The quick connect and alignment rod had numerous nicks and scratches.The devices were manufactured in 2006, 2007 and 2008 and show signs of extensive wear / usage.The functional evaluation found the quick connect and alignment rod functioned as intended.The cutting guide would not accept a pin due to damage.The drill was stuck in the drill guide so it could not be evaluated.The medical investigation concluded that this complaint reports that when drilling the femur the 4.8mm drill ¿seemed to catch in the bone¿ and this severely twisted the drill bit causing the drill bit to be stuck in the im drill guide.While using the quick connector on reverse power the quick connect trocar pins ¿snapped¿ in the bone.Per communication, ¿the piece that had been in the bone was successfully retrieved.¿ the procedure was completed with no delay or patient injuries.No further assessment is warranted at this time.A complaint history review found related failures; this failure mode will be monitored and assessed for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.The need for corrective action is not indicated.

Manufacturer Narrative

Additional information has identified that this event should be re-evaluated for mdr reporting.The new information states that the device broke inside the patient, therefore, it was determined that this case does meet the threshold for reporting and is a reportable event.If further details are provided,our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.Correction (reportable mdr).

• Brand Name: PF ANT CUT GUIDE LT
• Type of Device: PRSTHSSKNEFMOOTILNNCNSTRINDCMETMTALOLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9443752
• MDR Text Key: 170083715
• Report Number: 1020279-2019-04345
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010573117
• UDI-Public: 03596010573117
• Combination Product (y/n): N
• PMA/PMN Number: K113038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71563410
• Device Catalogue Number: 71563410
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 12/10/2019
• Supplement Dates Manufacturer Received: 11/13/2019; 11/13/2019; 11/13/2019
• Supplement Dates FDA Received: 03/05/2020; 03/05/2020; 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1