MAUDE Adverse Event Report: AMPLITUDE GENERAL KNEE INTRUMENTATION; HEADED PIN LENGTH 70MM

Model Number 2-0201302

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 09/24/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, during the removal of a headed pin length 70mm (instrument), it was detected that the extremity of the pin was broken.The broken part was in the cancellous bone and remained implanted.A surgery was decided by the surgeon after the post-operative mobilisation, to remove the broken part.

Manufacturer Narrative

The review of the internal vigilance database reveals that 3 others incidents were recorded for headed pin breakage with remained part in the patient.Since 2013, (b)(4) pins were manufactured and put in the market.The rate is (b)(4).One incident occurred in 2013 for which the conclusion was identify that the breakage was due to a misuse or a hard patient's bone with a higher resistance than usual.2 others incidents were recorded in 2021 from the same surgeon (see mfr report number 3009590-2021-00001 submission name (b)(4), and mfr report number 3009590-2021-00002, submission name (b)(4)).For which the involved devices were not returned and the origin of the breakage could not be established, but we cannot exclude the use of a bended device.For this incident, only distal part was returned (part which was into the patient bone).It is approximatively 3cm long.The proximal part was discarded by the healthcare facility.Due to the fact that the batch number was on the discarded part, the identification of the pin is not possible.The analysis of the manufacturing history records could not be performed.The visual analysis show that the broken pin does not shows signs of buckling.The broken part does not show sign of wear.The tip is not blunt.There is no rust observed.The visual analysis of the breakage profile indicates that the breakage seems not due to wear of the pin or fatigue breakage, but could be due to excessive stress beyond the elastic limit of the material.In conclusion and according to the element in our possession, the origin of the breakage could not be determined with certainty, but we cannot exclude an excessive stress.

• Brand Name: GENERAL KNEE INTRUMENTATION
• Type of Device: HEADED PIN LENGTH 70MM
• Manufacturer (Section D): AMPLITUDE; 11 cours jacques offenbach; valence, 26000 ; FR 26000
• MDR Report Key: 12678918
• MDR Text Key: 282218171
• Report Number: 3009590742-2021-00005
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Date Manufacturer Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention