MAUDE Adverse Event Report: LIMACORPORATE SPA H-MAX S STEM EXTRACTOR

Model Number 9046.10.235

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/13/2016

Event Type  malfunction  

Manufacturer Narrative

The check of the dhr of the lot # involved (extractor: lot #200706623; stem positioner: lot #2015ap006) did not show any anomalies on the (b)(4) extractors and (b)(4) stem positioners manufactured with the same lot#.No other complaint were received on these lot #.We will submit a final report once our investigation is concluded.

Event Description

During a hip revision surgery performed on (b)(6) 2016, the surgeon was about to remove a h-max s stem.In order to remove the stem, he screwed the stem extractor (code #(b)(4), lot #200706623) into the stem positioner (code #(b)(4), lot # 2015ap006).The stem was well fixed and took almost two hours to remove it.The tip of the stem extractor broke off inside the stem positioner.No reported consequences for the patient.Event occurred in (b)(6).

Manufacturer Narrative

Check of the dhrs: the check of the dhrs of the lots involved (extractor: lot #0706623; stem positioner: lot #15ap006) did not show any anomalies on the (b)(4) manufactured with the same lot#.No further complaints received on the lot#0706623.Only one additional complaint was received on the lot #15ap006.Instrument analysis: the instruments were returned to limacorporate for analysis.It was confirmed that the thread of extractor was broken.However, by visual inspection root cause of the breakage was the incorrect use of the instrument during surgery.As a matter of fact, the instrument appeared to be worn on just one side, as the surgeon punched it laterally.In conclusion, considering that up today no further complaints were received on the stem extractor lot #0706623, the manufacturing documentation is up to specification and the instrument has signs of wear/damage due to incorrect usage, we can hypothesize that root cause of the event is surgical error.Event not product related.Pms data: based on our pms data, we are aware of only this complaint on product code 9046.10.235 on (b)(4) manufactured.No corrective action implemented due to this specific case.Limacorporate will keep the market monitored.

Event Description

During a hip revision surgery performed on (b)(6)2016, the surgeon was removing a h-max s stem.In order to remove the stem, he screwed the stem extractor (product code #9046.10.235, lot #0706623) into the stem positioner (code #9046.10.230, lot # 15ap006).The stem was well fixed and took almost two hours to remove it.The tip of the stem extractor broke off inside the stem positioner.No reported consequences for the patient.Event occurred in new zealand.

• Brand Name: H-MAX S STEM EXTRACTOR
• Type of Device: H-MAX S STEM EXTRACTOR
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 6636198
• MDR Text Key: 77636161
• Report Number: 3008021110-2016-00077
• Device Sequence Number: 1
• Product Code: HWB
• 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
• Type of Report: Initial,Followup
• Report Date: 10/07/2020

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 Operator: Health Professional
• Device Model Number: 9046.10.235
• Device Catalogue Number: 9046.10.235
• Device Lot Number: 0706623
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/13/2017
• Supplement Dates Manufacturer Received: 09/26/2016
• Supplement Dates FDA Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization