MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR - ANATOMIC RESECTION JIG; SMR - ANATOMIC RESECTION JIG (KWT, HSD)

Model Number 9013.50.304

Device Problems Entrapment of Device (1212); Material Fragmentation (1261); Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 07/29/2019

Event Type  malfunction  

Manufacturer Narrative

By checking the manufacturing chart of the lot #16aq0d7 no anomaly was found.This is the first and only complaint received on this lot#.We will submit a final mdr once the investigation will be concluded.

Event Description

Intraoperative issue occurred during anatomic smr surgery performed on the (b)(6) 2019.During surgery, the pin got stuck into the smr - anatomic resection jig cod.9013.50.304 lot #16ao0d7.According to the info reported, the surgeon could not take the pin out, and consequently metal shavings went everywhere when forced in.The surgeon then took care to remove these pieces of metal.The event caused 10 minutes of prolonged surgery.Event occurred in (b)(6).

Manufacturer Narrative

Dhrs check: by checking the manufacturing chart of the resection jig with lot #16aq0d7, no anomaly was found on the 50 resection jigs belonging to the same lot#.No information on the code/lot# of the pin, thus the dhrs check was not possible for the pin.This is the first and only complaint received on the lot# of the resection jig involved (16aq0d7).Instrument analysis: the involved instrument was not available to be returned to limacorporate for analysis.We only received some pictures of the instrument with the pin stuck inside one of the holes, but no deep inspection is possible to confirm their conditions.Without the instrument and pin in our hands, we cannot establish a definitive cause for this seizure: no accurate visual inspection of the surface of the pin can be performed, no dimensional check can be performed on the pin nor on the jig holes, no functional checks can be performed.However, according to the analysis of previous similiar complaints received, where we could analyze the affected pieces, a damaged external surface of the pin can strongly contribute to the seizure.In this specific case it was not possible to verify the conditions of the pin, however, we can speculate that a damage due to the repeated (and maybe inaccurate) use of the pin over time could have contributed to the event.Corrective actions: after receiving previous similar complaints, in may 2016 the technical drawing of the resection jigs (codes 9013.50.304 and 9013.52.304-305) was adjusted to slightly increase the holes diameter of the jig and therefore further reduce the intra-op risk of seizure of the pin into the jig holes.The jig involved in this complaint belongs to the previous version of the drawing.According to our pms data, the occurrence rate of this kind of issue is (b)(4) (resection jigs code 9013.50.304 and 9013.52.304-305).Only one similar case has happened with the improved version of the jigs (manufactured after the drawing adjustment introduced in 2016), meaning an occurrence rate of (b)(4).Both these occurrence rates are overestimated because they do not consider the reuse of the instrument.Most of these issues happened after several uses of the resection jigs or of the pins.None of these cases had serious consequences on the patient.Limacorporate will continue monitoring the market to promptly detect any further similar events and assess the effectiveness of the corrective action performed.

Event Description

Intraoperative issue occurred during anatomic smr surgery performed on the (b)(6) 2019.During surgery, the pin got stuck into the smr anatomic resection jig cod.9013.50.304 lot #16aq0d7.The code/lot# of the pin is not known.According to the info reported, the surgeon could not take the pin out and when the pin was forced in, metal shavings were released.The surgeon was then able to remove all these shavings.Estimated number of uses on the instrument in unknown.The event caused 10 minutes of prolonged surgery.The procedure was positively completed after this issue.Event happened in australia.

• Brand Name: SMR - ANATOMIC RESECTION JIG
• Type of Device: SMR - ANATOMIC RESECTION JIG (KWT, HSD)
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, 33038 ; IT 33038
• MDR Report Key: 8864756
• MDR Text Key: 215135045
• Report Number: 3008021110-2019-00090
• 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: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9013.50.304
• Device Lot Number: 16AQ0D7
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization