MAUDE Adverse Event Report: LIMACORPORATE S.P.A. DELTA CURVED IMPACTOR

Model Number 9055.51.035

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The check of the dhr of the lot # involved did not show any pre-existing anomaly on the 11 pieces of delta cup curved impactor manufactured with lot #201402401. This is the first and only complaint received on this lot#. Limacorporate received and analyzed the cup impactor. A visual analysis confirmed that the impact surface (or flange) is broken and detached from the impactor body; detachment of the flange occurred corresponding to the welding between flange and body. A technical analysis carried out on the instrument showed that: the welding of the flange to the impactor body was performed according to specifications; no manufacturing process deficiency was detected; the flange appears to be heavily deformed likely due to repeated off-axis impacts; the repeated off-axis impacts could have significantly led to the failure of the welding. We don't know how many times this impactor, manufactured in 2014, has been used before breaking; it is possible that, when impacting the cup, the instrument was subjected to multi-axial forces and repeated stresses that could have contributed over time to the breakage of the impact surface. Pms data: this is the first and only similar complaint received on product code # 9055. 51. 035, involving the breakage of the impact surface, on a total of (b)(4) devices manufactured with this product code. No corrective actions planned at the moment. Limacorporate will keep monitored the market to promptly detect a possible recurrence of such issue.

Event Description

Intra-operative breakage of the impact surface of the delta cup curved impactor (model #9055. 51. 035, lot# 201402086) during cup impaction. No reported consequences for the patient. No prolonged surgery time. Event occurred in (b)(6).

Manufacturer Narrative

The check of the dhr of the lot # involved did not show any pre-existing anomaly on the 11 pieces of delta cup curved impactor (code #9055. 51. 035) manufactured with lot #201402401. This is the first and only complaint received on this lot #. We will submit a final mdr once we complete our investigation.

Event Description

Intra-operative breakage of the impact surface of the delta cup curved impactor (model # 9055. 51. 035) during cup impaction. No reported consequences for the patient. No prolonged surgery time. Event occurred in (b)(6).

• Brand Name: DELTA CURVED IMPACTOR
• Type of Device: CURVED IMPACTOR
• 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
• MDR Report Key: 6713289
• MDR Text Key: 256561546
• Report Number: 3008021110-2016-00109
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K112898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other

Reporter Occupation

• Type of Report: Initial,Followup

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 9055.51.035
• Device Lot Number: 201402401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 10/27/2016
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 02/20/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse