MAUDE Adverse Event Report: LIMACORPORATE S.P.A. T HANDLE - MINIZIMMER

Model Number 9095.11.205

Device Problem Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/29/2021

Event Type  malfunction  

Manufacturer Narrative

By the check of the device history records, no pre-existing anomaly was detected on the instruments that belong to the lot number involved (1490891).No other complaints registered on this lot number.We will submit a final report as soon as the investigation will be completed.

Event Description

Intra-operative issue occurred on (b)(6) 2021: the screw of the t-handle (product code 9095.11.205, lot number 1490891) fell.According to the information received, the instrument was used in about 400 surgeries.The surgery was completed without negative consequences nor prolongation of the surgical time.Event occurred in slovakia.

Event Description

Intra-operative issue occurred on 29th october 2021: the screw of the t-handle (product code 9095.11.205, lot number 1490891) fell.According to the information received, the instrument was used in about 400 surgeries.The surgery was completed with another instrument that was available in the operating room, without negative consequences nor prolongation of the surgical time.This event occurred in slovakia.

Manufacturer Narrative

The device history records of the lot number involved (1490891) were checked without detecting any pre-existing anomaly on the 21 instruments that belong to the same lot number.This is the first and only complaint received on this lot number.The instrument was returned to limacorporate, however, it was disassembled and the screw (subcomponent object of the reported issue) was not present, therefore no specific analysis could be performed on it.According to the instrument drawing, the screw is fixed into its position using a high-temperature resistant glue.The visual inspection of the instrument, confirmed that the two internal spheres, that allow the coupling of the handle to the zimmer attack, were missing as well.No deviation was detected by the check of the dhrs, meaning that the instruments of the lot number involved (1490891) were released compliant to the specifications valid at the time of the production of the lot.In conclusion, we cannot determine with certainty the root cause of this intra-operative issue, however a possible hypothesis for the reported screw loosening may be related to the repeated (instrument was used in about 400 surgeries) and maybe inaccurate use/cleaning of the instrument over time.An incorrect handling during the cleaning process may in fact have contributed to the screw loosening and consequent instrument disassembly (e.G.The screw is not intended to be disassembled and reassembled during the cleaning, this could otherwise cause loss of fixation).Limacorporate is aware of two similar incidents (including the one object of this complaint).On the total number of instruments manufactured with code 9095.11.205, the occurence rate is about 0.28%.However this is an overestimation as it does not consider that these instruments are re-usable.

• Brand Name: T HANDLE - MINIZIMMER
• Type of Device: T HANDLE - MINIZIMMER
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via naizonale 52; via naizonale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via naizonale 52; villanova di san daniele, udine 33038
• MDR Report Key: 13964726
• MDR Text Key: 298234647
• Report Number: 3008021110-2022-00022
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• PMA/PMN Number: (CLASS I)
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 9095.11.205
• Device Catalogue Number: 9095.11.205
• Device Lot Number: 1490891
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2022
• 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): Hospitalization