MAUDE Adverse Event Report: LIMACORPORATE S.P.A. INSERTER-EXTRACTOR HANDLE; KWT, HSD

Model Number 9013.02.303

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2015

Event Type  malfunction  

Event Description

The surgeon was impacting the definitive stem and humeral body into the patient.The force of the mallet hitting the impactor handle (model # 9013.02.303) caused the proximal pin to displace and fall from the impactor handle to the floor.No consequences for the patient.The loss of the pin did not affect its function as the pin was displaced almost at the point when the prosthesis was all the way home.The event occurred in (b)(6).

Manufacturer Narrative

The check of the manufacturing charts related to the lot # involved ((b)(4)) did not show any pre-existing anomaly.A total of (b)(4) pieces were produced with this lot # by our supplier ((b)(4) solutions), and we received no other complaints on this lot #.We are going to analyze the instrument involved and then provide our final report.

Manufacturer Narrative

No anomaly was detected by checking the dhr of the lot # involved (2014aa433).A total of (b)(4) pieces were manufactured with this lot # and we have received no other complaints on this lot #.; this is the first and only similar complaint reported on the model # 9013.02.303.We received the instrument involved.The dislodged pin and the corresponding hole in the impactor body were measured and a slight dimensional anomaly was detected in the diameter of both the pin and the hole (i.E., the pin was slightly under-dimensioned and the hole slightly over-dimensioned).In (b)(4) 2015, before becoming aware of this type of complaint, a slight adjustment (a reduction) in the tolerances of the pin holes in the impactor body was made which reduces the risk of occurrence of similar issues.No similar complaints have been received on instrument part number 9013.02.303.Limacorporate will continue to monitor complaints on this product.

Event Description

The surgeon was impacting the definitive stem and humeral body into the patient.The force of the mallet hitting the impactor handle (model # 9013.02.303) caused the proximal pin to displace and fall from the impactor handle to the floor.No consequences for the patient.The loss of the pin did not affect its function as the pin was displaced almost at the point when the prosthesis was all the way home.The event occurred in (b)(6).

• Brand Name: INSERTER-EXTRACTOR HANDLE
• Type of Device: KWT, HSD
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; san daniele del friuli, udine 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE S.P.A.; IT
• Manufacturer Contact: giulio puppa ; via nazionale 52; san daniele del friuli, udine 33038 ; IT 33038
• MDR Report Key: 4868107
• MDR Text Key: 18380359
• Report Number: 3008021110-2015-00023
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K100858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9013.02.303
• Device Lot Number: 2014AA433
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2014
• 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