MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER NATURAL NAIL THREADED PIN; TRAUMA INSTRUMENT

Catalog Number 00249004732

Device Problem Failure to Advance (2524)

Patient Problem No Patient Involvement (2645)

Event Date 01/12/2017

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.This report is number 3 of 3 mdrs filed for the same event (reference 1822565-2017-00520 / 00521).

Event Description

It is reported that during testing of the lag screw reamer and pins, the pins became stuck within the reamer.These were tested outside of any procedure, and had no patient impact.

Manufacturer Narrative

This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.The lag screw reamer and two pins were received for evaluation.The dimensions taken were within specification.It was found that the pin is fractured which remains inside the cannulation of the returned reamer.Also both the returned pins are bent into "u" shapes and exhibit scratches.The device history records were reviewed and no deviations or anomalies were identified.This device is used for treatment.The complaint history reviews were conducted for the devices and found no additional complaints for the same lots.Page 15 of the surgical technique (97-2493-002-00 rev 8 natural nail cephalomedullary standard surgtech-vfinal) states ¿caution: both 3.0 mm and 3.2 mm instruments (guide pins, depth gauges, reamers, taps, pin sleeves) are available.The 3.2 mm versions of the instruments can easily be distinguished as they have gold coating on them.The 3.0 mm and 3.2 mm instruments cannot be used interchangeably.Mixing of these instruments can lead to lag screw mis-measurement which could result in patient injury and/or damage to the instruments.¿ a likely root cause is that a 3.2mm pin was used with a reamer designed for a 3.0mm pin.Multiple mdr reports were filed for this event, please see associated reports: 00521-1 and 00520-1.

• Brand Name: ZIMMER NATURAL NAIL THREADED PIN
• Type of Device: TRAUMA INSTRUMENT
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6306885
• MDR Text Key: 66675558
• Report Number: 0001822565-2017-00522
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK091566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Assistant
• Type of Report: Initial,Followup
• Report Date: 03/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 00249004732
• Device Lot Number: 63408856
• Other Device ID Number: (01)00889024063952(10)63408856
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1