MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE BAL SIZER DISTRACTOR; ATTUNE INSTRUMENTS : SIZING/MEASURING INSTRUMENTS

Catalog Number	254400519
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The bal sizer distractor have been returned to the company for investigation.However, the mating part of balance sizer distractor was not returned despite of three follow-up requests to do so.The bal sizer distractor have been returned to the company for investigation.However, the mating part of balance sizer distractor was not returned despite of three follow-up requests to do so.Similar previous complaints were received for this product.This complaint is associated with the distractor mechanism of the attune balanced sizer being difficult to turn.Upon inspection of the returned device, significant resistance was confirmed.The ifu packaged with the balanced sizer (ifu-0902-00-836) indicates that moving parts should be lubricated after cleaning and prior to sterilisation.This should be completed after each use.It is not known whether this step was completed in the regular use of the device returned as part of this complaint.Following a previous complaint for the same failure mode ((b)(4)), a preliminary risk assessment (pra) was conducted ((b)(4)) which concluded there to be no patient harm.This correlates with this complaint where no patient harm was reported.Capa-(b)(4) was initiated following previous similar complaints and a design change was completed via (b)(4) to reduce the risk of galling if the ifu is not followed.As there is no patient effect, and since a design solution has been developed, no additional action is identified, and the post market surveillance procedure should be used to log and trend any future complaints.The returned part was forwarded to the design team.Their report states: ''signs of use but no visible damage or signs of misuse apparent to the threads or the rest of the instrument.Mating part of balanced sizer distractor not returned for investigation.Male (returned) part was assembled with mating part (b)(4) available in r&d and engages fully with no reduction of functionality.Unable to determine route cause without mating part.It was unlikely that a manufacturing defect was present.No corrective action is required.Use thread gauge to ensure component conforms to print.Post market surveillance is per (b)(4).'' a search of the complaint database did not show any additional reports against the lot code.Depuy considers the investigation closed at this time.Should additional information be received, the investigation will be reviewed and may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the balance sizer threads do not work properly.
Additional Manufacturer Narrative
Pc-(b)(4).The reported event has been evaluated and will be monitored.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch , a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE BAL SIZER DISTRACTOR
• Common Device Name: ATTUNE INSTRUMENTS : SIZING/MEASURING INSTRUMENTS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7960036
• Report Number: 1818910-2018-72294
• Device Sequence Number: 16564595
• Product Code: HWT
• UDI-Device Identifier: 10603295384403
• UDI-Public: 10603295384403
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 254400519
• Device Lot Number: ABC32617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 10/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1