MAUDE Adverse Event Report: LIMACORPORATE S.P.A. BONE SCREW Ø6,5 H.30MM

Model Number 8420.15.030

Device Problems Component or Accessory Incompatibility (2897); Loosening of Implant Not Related to Bone-Ingrowth (4002)

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

Event Date 04/25/2019

Event Type  malfunction  

Manufacturer Narrative

By checking the manufacturing charts of the involved lot#s no pre - existing anomaly was found.This is the first and only complaint received on these lot #s.We will submit a final report once the investigation will be concluded.

Event Description

Intra-operative issue occurred on the (b)(6) 2019.During hip replacement, delta-rev.-tt acet.Cup 50mm (not marked in usa) was implanted but 2 of the 3 screws did not match the holes of the delta revision tt cup.The cup went lose after 2 screws were screwed in already.Therefore, the surgeon removed the cup and changed it with the next available size.The screws involved in the issue are the following: bone screw ø6,5 h.30mm, code #8420.15.030, lot #1814574, ster.#1800324.Bone screw ø6,5 h.30mm, code #8420.15.030, lot #1814976, ster.#1800329.Bone screw ø6,5 h.35mm, code #8420.15.040, lot #1812983, ster.#1800276.The surgeon was satisfied with the final stability.Event occurred in (b)(6).

Event Description

Intra-operative issue occurred on the (b)(6) 2019, during hip replacement surgery.The surgeon had implanted the delta-rev.-tt acet.Cup 50mm (code #5533.38.050, lot #1802976, ster.#1800141).While he was trying to implant the bone screws to fix the cup, it was noted that 2 out of the 3 screws, did not match the holes of the delta revision tt cup.The cup went loose after 2 screws were screwed in already.Therefore, the surgeon removed the cup and changed it with the next available size, causing 25 mins of prolonged surgery time.The surgeon was satisfied with the final stability and no other consequence for the patient has been reported.The screws involved in the issue are the following: bone screw ø6,5 h.30mm, code #8420.15.030, lot #1814574, ster.#1800324; bone screw ø6,5 h.30mm, code #8420.15.030, lot #1814976, ster.#1800329; bone screw ø6,5 h.35mm, code #8420.15.040, lot #1812983, ster.#1800276.Event happened in austria.Note: the involved cup is not marketed in the usa.This event was reported to fda because the screws are marketed in the usa.

Manufacturer Narrative

Dhrs check: by checking the manufacturing charts of the involved screws lots (1814574, 1814976, 1812983), no pre-existing anomaly was found.We also checked the dhrs of the involved cup (lot#1802976) and no pre-existing anomaly was found.This is the first and only complaint received on these lots.Components analysis: we received the involved screws and cup for investigation.The components underwent a visual and dimensional check, with the following results: all the screws dimensions were compliant to specs and in-line with the relevant drawings; 3 out of the 6 acetabular cup holes were visibly damaged; 2 out of the 6 acetabular cup holes resulted to be slightly ovalized (maximum value of the hole diameter slightly overdimesioned); according to the event description, three of the six holes were used in combination with the screws, and this was confirmed by the damages visible on the three holes.Moreover, in two cases out of three, the screws passed through the holes, probably causing the deformation of the two holes due to the forces applied in the attempt to tighten the screws.A functional test was also performed, to evaluate in which conditions the screw could pass through the hole.According to our analysis, the screw can pass only in case of high stress applied and depending on the surgeon's implanting modality: the screw is inserted in a very angled position, due to lack of grip between screw and bone, the screw spins freely, nevertheless, the surgeon does not note the grip is missing and continues screwing.In these condition, a damage to the cup hole could occur and consequently the screw could pass through.No specific action for this case.Limacorporate will continue monitoring the market to promptly detect any further similar event.

• Brand Name: BONE SCREW Ø6,5 H.30MM
• Type of Device: BONE SCREW Ø6,5 H.30MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, 33038 ; IT 33038
• MDR Report Key: 8577268
• MDR Text Key: 149795896
• Report Number: 3008021110-2019-00058
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K172456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8420.15.030
• Device Lot Number: 1814574
• Initial Date Manufacturer Received: 04/26/2019
• Initial Date FDA Received: 05/03/2019
• Supplement Dates Manufacturer Received: 04/26/2019
• Supplement Dates FDA Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization