MAUDE Adverse Event Report: AMPLITUDE ANATOMIC; HEADED PIN LENGHT 70 MM

Model Number 2-0201302

Device Problem Fracture (1260)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

This report is associated to another report (mfr report number 3009590742-2021-00001, submission name (b)(4)) for headed pin breakage into the patient's bone following the use of a 5-in-1 femoral resection guide.This incident was reported retrospectively and no precise data was provided (it couldn't be confirmed from the reporter if the breakage of the headed pin occur during the hold of the 5-in-1 femoral resection guide or during the hold of the tibial cutting guide.) without the return of the broken headed pin (discarded by the healthcare facility) and the batch number unknown, the analysis of the manufacturing history records could not be performed.A replacement of all headed pins in stock at this healthcare facility has been performed and the devices were returned to us for analysis.The review of manufacturing history records of the returned devices shows that the headed pins have been manufactured according to our specifications and drawings including hardness.The devices have been inspected during manufacturing process and no anomaly was detected related to the incident.The review of the internal vigilance database reveals that 2 others incident were recorded for headed pin breakage with part remaining in the patient's bone.One incident occurred in 2013 and the other incident was recorded in 2021 by the same surgeon (see mfr report number 3009590742-2021-00001, submission name (b)(4)).The conclusions of the previous incident in 2013 concluded that the breakage was due to a misuse or a hard patient's bone with a higher resistance than usual.The visual analysis of the device returned (14 devices) by the healthcare facility show that the majority (9 on 14) are slightly bent.According to our instruction for use no103 for amplitude reusable surgical instruments : "inspection, functional testing and maintenance, it is specified that all instruments should be visually inspected and check for damage and wear.If damage or wear is noted during inspection, the instruments should be returned to amplitude and a replacement should be requested." without the return of the involved device (discarded by the healthcare facility) the breakage profile cannot be determined and root cause of the breakage cannot be clearly identified.According the elements in our possession the origin of the breakage cannot be established, but we cannot exclude the use of a bended device.

Event Description

This report is associated to another report (mfr report number 3009590742-2021-00001, submission name (b)(4)) for headed pin breakage into the patient's bone.This present incident has been identified following the interviews of the reporter.On a unknown date, during the removal of a headed pin length 70 mm for the implantation of anatomic total knee prosthesis, it was detected by the surgeon that the distal part of the headed pin was broken an remained implanted in the patient's bone.The surgeon decided to remain the broken part implanted in order to avoid doing damage when removing it.The foreign body finally migrated and go under the skin, requiring minimal intervention to removing it.

• Brand Name: ANATOMIC
• Type of Device: HEADED PIN LENGHT 70 MM
• Manufacturer (Section D): AMPLITUDE; 11 cours jacques offenbach; valence, 26000 ; FR 26000
• Manufacturer Contact: mireille lemery ; 11 cours jacques offenbach; valence, 26000 ; FR 26000
• MDR Report Key: 11513565
• MDR Text Key: 240578185
• Report Number: 3009590742-2021-00002
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2-0201302
• Device Catalogue Number: 2-0201302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other