MAUDE Adverse Event Report: LIMACORPORATE SPA FINNED TRIAL STEM DIA.12MM; KWT, HSD

Model Number 9013.04.120

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

No anomalies detected by checking the dhr of the lot# involved (16af01h) on a total of (b)(4) trial stem manufactured with the same lot #.No anomalies detected even by checking the dhr of the lot# involved (15aa017) on a total of (b)(4) conical reamer guides manufactured with the same lot #.We will send a final mdr once the investigation will be completed.

Event Description

During a smr reverse revision surgery done on (b)(6) 2017, when removing the trial stem (model# 9013.04.120, lot# 16af01h) and the conical reamer guide (model# 9013.52.116,lot# 15aa017) by using an inserter-extractor handle, the conical reamer guide came out, while the trial mini stem remained in patient.According to the info reported, surgery time was 5 minutes prolonged but the surgery was successfully concluded by using howarth and kocker.Event happened in (b)(6).

Event Description

During a primary surgery performed on (b)(6) 2017, when removing the construct mini trial stem (model# 9013.04.120, lot# 16af01h) + conical reamer guide (model# 9013.52.116,lot# 15aa017) by using an inserter-extractor handle, the conical reamer guide unexpectedly came out from the trial mini stem, which remained in the patient.According to the info reported, surgery time was prolonged of only 5 minutes (time needed to remove the trial mini stem from the femoral canal).The complaint source confirmed that the surgery was successfully concluded by using surgical instruments from the hospital's general orthopaedic instrument tray to extract the mini trial stem that was too deep in humeral canal.Event occurred in australia.

Manufacturer Narrative

We received code and lot number for the smr guide for conical reamer and for the mini trial stem.The check of the manufacturing chart of the lot # of guide involved (lot #2015aa017) did not show any anomalies on the 61 pieces manufactured with this lot#.No anomalies detected even by checking the manufacturing chart of the lot# of the mini stem involved (16af01h) on a total of 16 mini trial stem manufactured with the same lot #.No information about the other involved component (extractor handle) was received.Mini stem and conical reamer guide + its screw were received by limacorporate.They underwent a dimensional check with the following results: mini stem: no dimensional anomalies detected on the male taper of the stem.Moreover, by performing a functional test coupling the stem with a compliant screw, fully functionality of the stem female thread was also verified; conical reamer guide: no dimensional anomalies detected.Component found to be functional; · screw: it was impossible to measure the terminal distal part of the screw (part that guarantees the correct coupling between stem and guide) because it was too damaged.We don't know if this damage was pre-existing or occurred during the surgery (b)(6) 2017.Summarizing, different causes could have contributed to this intra-op issue (e.G.Pre-existing damage of distal part of screw, improper coupling between mini trial stem and guide, presence of tissue in the coupling mechanism between guide and extractor).Pms data: no other similar complaints involving a guide (9013.52.116) with a trial mini stem (9013.04.1x0) have been received by limacorporate.According to our pms data, the occurrence rate of such issue is 0.21%.No corrective action for this specific case.Limacorporate will continue monitoring the market to promptly detect the possible recurrence of this event.

• Brand Name: FINNED TRIAL STEM DIA.12MM
• Type of Device: KWT, HSD
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale,52; villanova di san daniele, 33038 ; IT 33038
• MDR Report Key: 6986363
• MDR Text Key: 91374965
• Report Number: 3008021110-2017-00101
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9013.04.120
• Device Lot Number: 16AF01H
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization