MAUDE Adverse Event Report: LIMACORPORATE SPA SMR REVERSE RESECTION JIG; KWT, HSD

Model Number 9013.52.304

Device Problems Entrapment of Device (1212); Sticking (1597)

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

Event Type  malfunction  

Manufacturer Narrative

The check of the dhr of the lot # involved (lot #15aa219) did not show any anomalies on the (b)(4) pieces manufactured with this lot#, thus indicating that the devices were compliant to specifications when they were released on the market.No other complaints reported on the same lot#.We will send a final report once the investigation will be completed.

Event Description

Intra operative issue occurred on (b)(6) 2018: a lima pin got stuck inside a hole of the smr reverse resection jig, model# 9013.52.304, lot# 2015aa219.No reported prolonged surgery time nor consequences for the patient.Approximate number of uses of the instrument involved is unknown.Event happened in (b)(6).

Manufacturer Narrative

The check of the dhr of the lot # involved (lot #2015aa219) did not show any anomalies on the 24 jigs manufactured with this lot#.No other complaints reported on the same lot#.The involved jig was returned to (b)(4), but the involved pin (model #9066.15.095) wasn't.No pictures of the pin was provided.The returned jig underwent a dimensional check: one (1) of the seven (7) holes of the resection jig resulted to be (very slightly) oval and very slightly under-dimensioned (max deviation -0.022mm), while the diameter of the remaining six (6) holes is compliant to drawing specifications.A functional check was performed with a new pin, which could pass through all the free holes of the returned resection jig, including the oval one.This was expected: in fact, the maximum allowable diameter of the pin (as per drawing) is lower than the measured minimum diameter of the jig hole (in the oval hole).Therefore, the most likely cause for the intra-op issue is that the pin external surface was very damaged (due to previous and possible improper usages of the pin), thus preventing a correct sliding of the pin through the oval hole.No corrective action for this specific case.According to our investigation, the resection jig involved is fully functional with a new (undeformed) pin.After receiving previous similar complaints, in may 2016 the technical drawing of the smr reverse resection jig 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, in case that the external surface of the pin is very damaged.For the similar complaints where we could analyze the affected pieces, the strongly damaged external surface of the pin was found to be the cause of the seizure between pin and jig.In all these cases, no adverse effects for patients were reported.The resection jigs involved in all the similar complaints reported were manufactured before the drawing improvement.(b)(4) will continue to monitor the market to promptly detect the possible recurrence of this issue and assess the effectiveness of the corrective action performed.

Event Description

Intra operative issue occurred on (b)(6) 2018: a lima pin got stuck inside a hole of the smr reverse resection jig, model# 9013.52.304, lot# 2015aa219.No reported prolonged surgery time nor consequences for the patient.Approximate number of uses of the instrument involved is unknown.Event happened in (b)(6).

• Brand Name: SMR REVERSE RESECTION JIG
• Type of Device: KWT, HSD
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale,52; villanova di san daniele, 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE S.P.A.; via nazionale,52; villanova di san daniele, 33038 ; IT 33038
• Manufacturer Contact: giulio puppa ; IT
• MDR Report Key: 6886076
• MDR Text Key: 89390024
• Report Number: 3008021110-2017-00086
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K100858
• 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

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9013.52.304
• Device Lot Number: 2015AA219
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Hospitalization