MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF SPHER HEAD SCREW 20MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Model Number 71332520

Device Problem Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2023

Event Type  malfunction  

Event Description

It was reported that during surgery, one (x1) ref spher head screw 20mm was inserted and removed.It was found a wire-like metal was coming out of the screw body.Using back up device, the surgery was completed 5 minutes surgical delay.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Manufacturer Narrative

The associated device was returned and evaluated.A visual inspection of the returned screw reveals a wire like metal is coming off of the screw.An engineering evaluation reveals through reviewing the incoming inspection report and document history review, the titanium bars of 22fb00756 met material requirement, and the product of 22hb01033 met the product requirement.From the appearance of the returned screw, the screw have serious scratch during the surgery.The screw went through the inserting and removing.And the wire came off the screw thread that is a part of the screw.Therefore, it is possible that the improper surgery caused the issue.To sum up, no further escalation will be completed.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review concluded that there are no prior escalated actions related to this part number and failure mode.This is a single use device, surgical technique or damage from misuse are likely potential factors that could contribute to the reported event.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: REF SPHER HEAD SCREW 20MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17302916
• MDR Text Key: 318947168
• Report Number: 1020279-2023-01437
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 03596010460455
• UDI-Public: 03596010460455
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K990666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71332520
• Device Catalogue Number: 71332520
• Device Lot Number: 22HB01033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2023
• Date Device Manufactured: 08/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1