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

Catalog Number 254401006

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary:the investigation confirmed the event of device breakage.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) 254401006 attune femoral impactor, lot number au5895370.Complaints databases searched on product code 254401006 identified previous complaints received for this failure mode.Visual examination of the product confirmed the device was broken.All pieces were reported removed, however, fragments were not returned.The lot number au5895370 indicates that this device is from an annealed batch of impactors.Expert opinion (refer dve-002822-dvr) indicates that this failure mode is associated with environmental stress cracking (esc).The lot au5895370 of the attune femoral 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 (dva-107261-pra) 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 (qrb-103089410) 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 (1 in 1,000 < occurrence < 1 in 100).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.Device was used for treatment, not diagnosis.

Event Description

It was reported that 3 attune impactors were cracked and needed to be replaced along with 1 attune size 7 rp articulating trial.No time added to any cases.Review of the returned product by the product analyst determined that this product was in fact broken, not just cracked.All components were accounted for.

• Brand Name: ATTUNE FEMORAL IMPACTOR
• Type of Device: ATTUNE INSTRUMENTS : IMPACTORS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND - 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380 ; 6107428552
• MDR Report Key: 8404961
• MDR Text Key: 139081436
• Report Number: 1818910-2019-86819
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295130222
• UDI-Public: 10603295130222
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254401006
• Device Lot Number: AU5895370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2019
• Date Device Manufactured: 03/22/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1