MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH SET SCREW, 8 MM, 21 MM, HEX 3.5 MM; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products and therapy date.Detail of product: item number unknown, item name znn cmn nail hip, lot # unknown.The manufacturer did not receive x-rays but received other source documents for review.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.Attempts to obtain additional information have been made; however, no more is available.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available, an updated report will be submitted.(b)(4).
Event or Problem Description
It was reported that during surgery the screw was stuck and couldn't move any degrees.
Event or Problem Description
No change to previously reported event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected and additional information.Event: event happened during the surgery when the surgeon tried to insert the set screw.It was found that the screw was stuck and couldn't move any degrees.No issues of the patient reported.No delay reported.No relevant medical data has been received.No further due diligence required as all required information to support the conclusion is available or was already requested.Visual examination: the set screw has been returned for investigation.The visual examination shows that the thread of the screw is polished.This can be caused by trying to insert the set screw into the znn nail.No other damages or deformations can be seen.A review of the surgical technique was done.The correct lag screw insertion and set screw insertion is described.It can be assumed that the set screw was not correctly placed into the znn nail.The products are intended for treatment.The investigation results did not identify a non-conformance or a complaint out of box (coob).The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: SET SCREW, 8 MM, 21 MM, HEX 3.5 MM
• Common Device Name: ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10043123
• Report Number: 0009613350-2020-00213
• Device Sequence Number: 14223458
• Product Code: HSB
• UDI-Device Identifier: 00889024298620
• UDI-Public: 00889024298620
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2020

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 Model Number: N/A
• Device Catalogue Number: 47-2493-000-00
• Device Lot Number: 4503010041
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/16/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 05/11/2020
• Supplement Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other