MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR - INSERTER-EXTRACTOR HANDLE

Model Number 9013.02.303

Device Problem Break (1069)

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

Event Date 02/24/2021

Event Type  malfunction  

Manufacturer Narrative

This is the first and only complaint received on this lot #.We will send a final mdr once the investigation will be completed.

Event Description

During a shoulder primary surgery performed on (b)(6) 2021, the prong on the tip of the smr - inserter-extractor handle (product code 9013.02.303, lot# 14aa199) broke off.No effect was reported on the patient.According to the complaint source, the instrument was used as per surgical technique and the surgery was successfully completed.Event happened in (b)(6).

Event Description

During a shoulder primary surgery performed on (b)(6), 2021, the prong on the tip of the smr - inserter-extractor handle (product code (b)(4), lot# 14aa199) broke off while the instrument was being taken apart.The breakage occurred after the instrument was used and outside of the patient.No effect on the patient was reported.According to the complaint source, the instrument was used as per surgical technique and the surgery was successfully completed.No extension of surgical time was reported.Event happened in australia.

Manufacturer Narrative

This is the first and only medical complaint received on this lot #.The instrument involved in the complaint is not available to be returned to limacorporate for investigation.According to the complaint source, the instrument was used for a quite number of times (exact number of uses is not known).According to the reported information, the instrument breakage occurred after its use and while it was taken apart from the operation field.No consequences on the patient were reported.Based on the very few information available and taking into account that no further investigation on the instrument is possible (unavailable for being returned to limacorporate), no definitive conclusion can be drawn on the causes of the breakage of the instrument's prong.We can only give evidence that the instrument (reusable and used multiple times during years) had been manufactured in 2014 and the breakage occurred in (b)(6) 2021.Pms data this is the first complaint received on the intra-operative breakage of the inserter-extractor handles.According to limacorporate pms data, the occurrence rate of breakage of the inserter-extractor handles - belonging to the family codes 9013.02.303 is (b)(4).The occurrence rate is overestimated because it does not consider the reuse of the instruments.

• Brand Name: SMR - INSERTER-EXTRACTOR HANDLE
• Type of Device: INSERTER-EXTRACTOR HANDLE
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 11433706
• MDR Text Key: 240740803
• Report Number: 3008021110-2021-00014
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K100858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9013.02.303
• Device Lot Number: 14AA199
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other