MAUDE Adverse Event Report: H.P.F SPA H-MAX STEM POSITIONER

Model Number 9046.10.230

Device Problem Sticking (1597)

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

Event Type  malfunction  

Manufacturer Narrative

The manufacturer (hpf s.P.A) confirmed that no anomalies were detected by checking the manufacturing chart related to lot# 2014h4892 on a total of 10 stem positioners manufactured with this lot#.First and only complaint received on this lot# we will send a final mdr once the investigation will be concluded.

Event Description

During surgery, after extracting the stem, the positioner - model# 9046.10.230, lot#2014h4892- got stuck on h-max stem.No reported consequences for the patient, nor prolonged surgery time.Event happened in (b)(6).

Manufacturer Narrative

The manufacturer of the positioner involved (b)(4) confirmed that no anomalies were detected by checking the manufacturing chart related to lot# 2014h4892, on a total of 10 stem positioners manufactured with this lot#.This is the first and only complaint received on this lot#.Instrument's pictures, where the stem positioner seems to be separated in its three main components (threaded rod separated from handle body and from aligner + blushing), were received.Instrument analysis: the involved instrument was returned to us, while the stem was not available to be returned.We can reasonably speculate that the seizure happened as following described: during the removal phase of the stem that has to be explanted, the positioner was screwed on the stem; then, a stem extractor was screwed on the stem positioner and the inertial beater should have been used to extract the stem as per surgical technique; after extracting the stem, a seizure between stem (female thread) and positioner (male thread) was experienced; the stresses applied on the positioner in order to separate it from the stem, have been such as to cause the detachment of the threaded rod from the other instrument components.In order to further demonstrate our incident's hypothesis and states that the seizure was likely due to ruined threaded rod, a dimensional analysis on this instrument's detail was performed.The dimensional analysis done on the threaded rod confirmed that the threaded tip is not functional.In detail, the first thread ridge appears to be slightly deformed.An excessive tightening of the thread into the stem cavity, combined with wear of the instrument due to its use over time (estimated number of instrument uses unknown), could have significantly contributed to the seizure.Conclusions: the most likely cause for the stem positioner - stem seizure was an excessive tightening of the thread combined with wear of the instrument due to its use over time.No other similar complaints received on a stem positioner with model #9046.10.230.According to our investigation, this is not a product-related case.

Event Description

During a surgery, after extracting the h-max stem with the positioner, the male thread (threaded rod) of the positioner - model# 9046.10.230, lot#2014h4892- got stuck on the female thread of the h-max stem.No reported consequences for the patient, nor prolonged surgery time.Event happened in (b)(6).

• Brand Name: H-MAX STEM POSITIONER
• Type of Device: H-MAX STEM POSITIONER
• Manufacturer (Section D): H.P.F SPA; via pinzano al tagliamento 24; IT
• Manufacturer (Section G): LIMACORPORATE S.P.A.; via nazionale,52; villanova di san daniele, 33038 ; IT 33038
• Manufacturer Contact: giulio puppa ; via nazionale,52; villanova di san daniele, 33038 ; IT 33038
• MDR Report Key: 6803166
• MDR Text Key: 83223169
• Report Number: 3008021110-2017-00077
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112091
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9046.10.230
• Device Lot Number: 2014H4892
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/23/2017
• 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