MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5MM INSERTER CONNECTOR LONG R LONG; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	14-441043
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr's were filed in association with this reporting: 0001825034 -2019 -05591.Report source: foreign, event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.
Event or Problem Description
It was reported the device fractured and the patient retained the foreign body.No further information has been made available at the time of this reporting.
Event or Problem Description
No further information has been made available at the time of this reporting.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual inspection of the returned products noted the instruments were fractured, confirming the complaint.Further noted some wear on the instrument.Almost all of the green epoxy is worn off of the inserter connector.Device history record (dhr) was reviewed and no discrepancies were found.The root cause is determined as a design deficiency.A corrective action has been initiated previously due to the design deficiency of the product.No corrective actions, preventive actions, or field actions resulted after the investigation of this event.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d10, g4, g7, h1, h2, h4, h10.H4- device manufacturer date: (b)(6)2014 for lot# 172400 (b)(6)2014 for lot# 333050 corrected section: d4- lot# :172400, 333050 the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: 3.5MM INSERTER CONNECTOR LONG R LONG
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9481904
• Report Number: 0001825034-2019-05590
• Device Sequence Number: 259306
• Product Code: LXH
• UDI-Device Identifier: 00887868093715
• UDI-Public: 00887868093715
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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,Followup,Followup
• Report Date (Section B): 05/29/2020

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: 14-441043
• Device Catalogue Number: 14-441043
• Device Lot Number: ZB141043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 12/26/2019; 02/03/2020; 05/21/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 01/02/2020; 02/05/2020; 05/29/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 14-441044, INSERTER, LOT CODE7981111
• Outcome Attributed to Adverse Event: Other