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

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Fitting Problem (2183); Connection Problem (2900)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: item# 47-2493-000-00, lot# 4502405237, set screw, 8 mm, 21mm, hex 3.5 mm, item# 47-2485-095-10, lot# 2962002, znn, cmn lag screw, 10.5 mm, 95 mm, including set screw, item# 47-2493-210-13, lot# 2938084, z nail cpm 13mmx21.5cm 125 r.The complaint device (item# 47-2493-000-00) has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch 3500a will be submitted.The manufacturer did not receive other source documents for review.Device history record (dhr) was reviewed and no discrepancies were found.The following reports are associated with this event: 0009613350-2019 -00241 and 0009613350-2019-00242.A cause for this specific event cannot be ascertained as the investigation has not yet completed.As soon as supplemental information or investigation result becomes available an updated report will be submitted.(b)(4).
Event or Problem Description
It was reported that, during the initial surgery, there was an assembling problem with the set screw to the lag screw.It was stated that the tip of the set screw was fractured.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being filled to relay investigation result.Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend identified.Device analysis: visual examination: the set screw has been returned for investigation.The visual examination shows that the tip of the set screw is partially broken.This can be caused by incorrect placement of the set screw into the lag screw grooves.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).
Event or Problem Description
Please refer to report 0009613350-2019-00240.

• 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 GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8539355
• Report Number: 0009613350-2019-00240
• Device Sequence Number: 2444270
• 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): 02/14/2020

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: 4502405237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 02/14/2020
• 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