MAUDE Adverse Event Report: LIMACORPORATE CURVED CUP IMPACTOR

Model Number 9095.11.550

Device Problem Defective Component (2292)

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

Event Date 01/07/2021

Event Type  malfunction  

Manufacturer Narrative

By the check of the device history records, no pre-existing anomaly was detected on the instruments manufactured with the same lot#.This is the first and only complaint received in this lot# (19ag0kt).We will submit the final mdr as soon as the investigation will be completed.

Event Description

Intra-operative issue occurred during hip surgery on (b)(6) 2021: it was not possible to properly engage the curved cup impactor with code 909511550 and lot# 19ag0kt to the acetabular cup.According to the information received, the connection pin was too short.The surgery was completed with another available instrument and the issue caused 15 minutes of prolonged surgery time.Event occurred in (b)(6).

Event Description

Intra-operative issue occurred during hip surgery on (b)(6) 2021: it was not possible to properly engage the curved cup impactor with code 909511550 and lot 19ag0kt to the acetabular cup.According to the information received, the connection pin was "too short".The exact number of uses of the instrument is unknown, the complaint source was aware of one use only.The surgery was completed with another available instrument and the issue caused 15 minutes of prolonged surgery time.This incident occurred in italy.

Manufacturer Narrative

By the check of the device history records, no pre-existing anomaly was detected on the instruments released with the same lot number (19ag0kt).This is the first and only complaint received on lot n.19ag0kt.The instrument was returned to limacorporate for investigation.By a first inspection, it was confirmed that the pin was stuck and did not allow the correct use of the instrument.The pin was therefore disassembled: the subcomponents were disengaged and underwent a dimensional analysis.No anomaly that could have contributed to the issue was detected: the measured dimensions were found compliant to specifications.The part appears visibly damaged, making us believe that the pin got damaged during a previous usage of the instrument.It is possible that the pin bent in consequence of the repeated impaction performed to implant the acetabular cups.At this point, as the pin was no more in axis, it has seized, causing the impossibility to correctly engage the instrument to the acetabular cup.The analysis performed showed that: based on the device history records check, the instrument did not have any pre-existing anomaly, no dimensional defect that could have contributed to this issue was found during the inspection of the retrieved instrument, the instrument was found damaged, probably due to the repeated use (please note that these instruments are re-usable, and limacorporate cannot confirm the exact number of uses of the specific instrument).In conclusion, we believe that the reported issue was caused by the repeated and maybe inaccurate use of the instrument over time.Pms data: (b)(4).Please note that this occurrence rate is estimated as the number of incidents on the number of instruments (b)(4) manufactured, thus it is an overestimation because it doesn't consider the number of uses of the instruments (reusable).No corrective actions needed for this specific complaint.Limacorporate will continue monitoring the market to promptly detect any further similar event.

• Brand Name: CURVED CUP IMPACTOR
• Type of Device: CURVED CUP IMPACTOR
• Manufacturer (Section D): LIMACORPORATE; via nazionale 52; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 11222840
• MDR Text Key: 266409203
• Report Number: 3008021110-2021-00005
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K112898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

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 Model Number: 9095.11.550
• Device Lot Number: 19AG0KT
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/15/2021
• Initial Date FDA Received: 01/25/2021
• Supplement Dates Manufacturer Received: 01/15/2021
• Supplement Dates FDA Received: 02/11/2022
• 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