MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REV T AUGTRL 5MM SZ7LL; FEMORAL TRIALS

Catalog Number	252307201
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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
We sent our new attune revision sets at the first time to the customer and get them back with some rusted areas.We don´t exactly know when the incident occured.Patient status/ outcome / consequences? no.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: following review of the information received, it was concluded that it was unlikely that a potential product issue was present.The complaint shall be entered onto the complaints database and monitored through trend analysis.Should further information be received, then the complaint shall be reviewed and further investigation completed as required.Following receipt of a product photograph attached into ecm, this was reviewed and it was confirmed that there appeared to be discolouration/rust staining on the lettering of the product.Following receipt of 2x complaint products only, these were visually inspected and it was noted that no sign of discolouration or rust was evident on the products.It was noted that the product shown in the attached photograph was a size 3-4 product, whereas the products returned were both size 7-8 products.Complaints databases searched product lot so2038958, so2038942, so2038966, so2038954, so2040479, so2038960 & so2040436 identified no similar complaints received previously.It was noted that further information had been requested regarding the cleaning & sterilising parameters used, however, notification was received that: ¿ it is not possible to answer pcf questions concerning a complaint reported by orthokit/leihservice/loaner kit department as the issue was detected during a depuy synthes in-house inspection without knowing any previous procedures or operational steps.¿ it was concluded that: from the information reviewed, it was unlikely that a potential product issue was present.No corrective action is required and no further investigation is recommended.Post market surveillance is per sep 419.Device history lot: null.Device history batch: null.Device history review: null.

• Brand Name: ATTUNE REV T AUGTRL 5MM SZ7LL
• Common Device Name: FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8910349
• Report Number: 1818910-2019-101656
• Device Sequence Number: 286077
• Product Code: LXH
• UDI-Device Identifier: 10603295437277
• UDI-Public: 10603295437277
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 252307201
• Device Lot Number: SO2040436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2019
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 11/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1