MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF SPHER HEAD SCREW 60MM; PRSTHSS,HIP,SMI-CNSTRND,UNCMNTD,MTAL/PLYMR,NN-PRS,CLICUM-PHSPHTE

Catalog Number	71332560
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, while implanting a screw, several metal filaments appeared and were removed.Screw was not removed and fixed with a 20 screw.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and reportedly during the total hip replacement surgery several metal filaments appeared while implanting the screw.It was further communicated that the metal filaments were removed using hemostatic forceps.No significant delay or patient injuries are being reported.Since no harm to the patient is being reported no further medical assessment is warranted.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 complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re opened.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: patient information.Surgical procedure/post-operative care review.Device labeling (including technique guides, ifus, etc.) reportedly during the total hip replacement surgery several metal filaments appeared while implanting the screw.It was further communicated that the metal filaments were removed using hemostatic forceps.No significant delay or patient injuries are being reported.Since no harm to the patient is being reported no further medical assessment is warranted.

• Brand Name: REF SPHER HEAD SCREW 60MM
• Common Device Name: PRSTHSS,HIP,SMI-CNSTRND,UNCMNTD,MTAL/PLYMR,NN-PRS,CLICUM-PHSPHTE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8284427
• Report Number: 1020279-2019-00322
• Device Sequence Number: 19353052
• Product Code: MEH
• UDI-Device Identifier: 03596010463319
• UDI-Public: 03596010463319
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K990666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/12/2025
• Device Catalogue Number: 71332560
• Device Lot Number: 15JT58788
• Initial Date Received by Manufacturer: 01/07/2019
• Supplement Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 06/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR