MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIBIAL IMPACTOR; ATTUNE INSTRUMENTS : IMPACTORS

Catalog Number 254401003

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the investigation confirmed the reported event.The complaint shall be closed with a justified conclusion; it will be entered into the complaint database and monitored through trend analysis.The complaint sample consisted of (1) 254401003 attune fb tibial impactor, lot number au3207735.Visual examination of the product confirmed the device was cracked.A fragment was also found to be chipped off and missing.The impaction surface was heavily deformed.The lot number au3207735 indicates that this device is from an annealed batch of impactors.Complaints databases searched on product code 254401003 identified previous complaints received for this failure mode.Expert opinion (refer (b)(4)) indicates that this failure mode is associated with environmental stress cracking (esc).The lot au3207735 of the attune fb tibial impactor is an annealed lot.While annealing helps in reducing the internal stress in the molded part, a complete reduction in internal stresses of the device is not achievable.There is a wide range of cleaning agents used across hospitals and it is possible that some result in greater degradation in the robustness of the device from repeated exposure.A pra ((b)(4)) held in sep, 2012 when a similar device (attune fb impactor- 254401003) either cracked or broke into large pieces did not identify a potential patient harm based on the nature of the failure.Post pra evaluation (held in september 2012); a new additional failure observation was made and showed that in some instances the attune impactors fractured (either completely or partially) and resulted in small fragments.This issue led to qrb ((b)(4)) initiation on october 2014 and recommended a field correction in the form of a communication to device users for all 3 attune impactors- rp, fb & fem.The field safety notice stresses to ensure that no instruments or pieces of instruments are left in the surgical site prior to closure.There was no recommended field action other than this communication.Full lavage of the joint-space is recommended before and after implantation.Ifu 0902-00-836 contains wording relating to the importance of removing fragments from the surgical site.Both failure modes; patient harm & delay to surgery have been adequately covered in the risk assessment of the device and no further updates are required.The dfmea scores reflect the current failure rates of the device.However, in order to investigate the root cause and possibility of reducing this occurrence, capa-(b)(4) has been initiated and can be referenced for further details.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the attune fb impactor was discovered to have a crack in the surface during the case before it was used.The impactor was not used and different tray was acquired for impaction.The patient was not involved in any way.

• Brand Name: ATTUNE FB TIBIAL IMPACTOR
• Type of Device: ATTUNE INSTRUMENTS : IMPACTORS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380 ; 6107428552
• MDR Report Key: 8411785
• MDR Text Key: 138531529
• Report Number: 1818910-2019-86977
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295130192
• UDI-Public: 10603295130192
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/25/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 254401003
• Device Lot Number: AU3207735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2019
• Initial Date FDA Received: 03/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2013
• 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