MAUDE Adverse Event Report: LIMACORPORATE S.P.A. PHYSICA TIBIAL POSITIONER

Model Number 9065.88.130

Device Problems Difficult or Delayed Positioning (1157); Sticking (1597)

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

Event Date 09/23/2016

Event Type  malfunction  

Manufacturer Narrative

The check of the dhr of the lot # involved did not show any pre-existing anomaly on the (b)(4) pieces of tibial positioner manufactured with lot #2015ag08h.This is the first and only complaint received on this lot #.We will submit a final report when our investigation is concluded.

Event Description

Intra-operative issue involving the physica tibial positioner.The instrument was frozen with the implant and it was difficult to disengage them.Surgery time was not extended and no consequences for the patient were reported.Event occured in (b)(6).

Manufacturer Narrative

The check of the dhr of the lot # involved did not show any pre-existing anomaly on the (b)(4) pieces of tibial positioner manufactured with lot #2015ag08h.This is the first and only complaint received on this lot #.We received the instrument involved and we performed a dimensional check on it: no dimensional anomaly which could have contributed to the event was detected.The involved instrument is provided as alternative to the standard tibial impactor (model # 9065.88.110).Therefore, there is always a back-up instrument present in the operating theatre in case of malfunction of the 9065.88.130.The male and female threads of the involved instrument are functional.The disengagement of the instrument from the tibial plate is performed by rotating the red dial counterclockwise.It is unknown how the instrument was used during surgery, but the surgeon may have experienced some difficulties because of possible high strength applied when tightening the instrument, and then glove slipping on the dial when unscrewing the instrument.Hence, external factors could have caused the freezing of the instrument with the implant.The analysis performed on the instrument did not reveal any anomaly which could have contributed to the event.According to limacorporate post-market surveillance data, this is the first and only complaint received on the product code #9065.88.130 on a total of (b)(4) physica tibial positioner/aligner manufactured since 2014.This event was probably caused by external factors which are not product related.Limacorporate will continue monitoring the market to detect the possible recurrence of this issue.

Event Description

Intra-operative issue involving the physica tibial positioner (model # 9065.88.130).The instrument was frozen with the implant and it was difficult to disengage them.Surgery time was not extended and no consequences for the patient were reported.Event occurred in (b)(6).

• Brand Name: PHYSICA TIBIAL POSITIONER
• Type of Device: PHYSICA TIBIAL POSITIONER
• Manufacturer (Section D): LIMACORPORATE S.P.A.; 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 ; via nazionale, 52; villanova di san daniele, 33038 ; IT 33038
• MDR Report Key: 6676963
• MDR Text Key: 79031280
• Report Number: 3008021110-2016-00098
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K141934
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9065.88.130
• Device Lot Number: 2015AG08H
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2015
• 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