MAUDE Adverse Event Report: ZIMMER GMBH NCB, PH GUIDE WIRE¸ 1.6, WITH THREAD, 190 MM; N/A

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual device reported is not marketed in usa, but devices with similar characteristics (i.E k061211) are marketed in usa, and therefore this report was filed.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.Additional information has been requested and is currently not available.Notes: the implantation and explantation dates are left empty as the device involved in this complaint is an instrument.Hence, no expiration date is captured, for the same reason.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.Zimmer biomet¿s reference number of this file is (b)(4).Not returned.
Event or Problem Description
It was reported that during surgery, tip of the guide wires broke and remained in the patient's body as the removal procedure would have needed expanded access area and obtain greater tissue damage.
Additional Manufacturer Narrative
This follow-up report is being filled to relay investigation result.Additional and corrected information are filled in the following fields: additional: h2 - h6.Correction: b4 - g4 - g7 - h10.Dhr review: as no lot number was provided, the device history records could not be reviewed.Trend analysis: 2 similar investigated events with 10 involved products (device fracture) within last 6 months for item number 02.01362.116 have been found.However, an issue evaluation has already been initiated for the same issue, no further actions are required.Event description: it was reported that during surgery, the tip of the guide wire broke and that remained in the patient's body as the removal procedure would have needed expanded access area and obtain greater tissue damage.Review of received data: the received x-rays are undated.The review was done by dr.(b)(6).Right shoulder ap-view and slight internal rotation: broken guide wire visible at the level of the lowest screw screw.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: this device is intended for treatment.The compatibility check could not be performed as only one product has been reported.Biocompatibility specification: in accordance with iso 10993-1:2009 the ncb implants df, ph and pt are categorized as implantable devices with tissue/bone contact for more than 30 days (c - permanent).Conclusion: it was reported that during surgery, the tip of the guide wire broke and that remained in the patient's body as the removal procedure would have needed expanded access area and obtain greater tissue damage.No product was returned to zimmer biomet for in-depth analysis.However, a deep product analysis (investigation) was performed in complaint (b)(4).In that complaint 9 guide wires with the same ref were broken during the surgery.The 9 guide wires were investigation by material group.The conclusion was that a possible overload in the thread area was occurred.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).
Event or Problem Description
Please refer to report 0009613350-2019-00100.

• Brand Name: NCB, PH GUIDE WIRE¸ 1.6, WITH THREAD, 190 MM
• Common Device Name: N/A
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8389588
• Report Number: 0009613350-2019-00100
• Device Sequence Number: 1922170
• Product Code: LXH
• UDI-Device Identifier: 00889024290280
• UDI-Public: 00889024290280
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 02.01362.116
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 02/06/2020
• 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: Hospitalization; Required Intervention