MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE CONV FB PS TB TRL SZ5; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Catalog Number	254500975
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no product was received back for investigation.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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
Spring came off of an instrument and was lost in theatre.Staff report that the instruments were checked at the beginning of the surgery and all was ok.X-ray was used to try and locate the spring.Not identified on x-ray and not found in theatre.Not resolved.

• Brand Name: ATTUNE CONV FB PS TB TRL SZ5
• Common Device Name: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9150517
• Report Number: 1818910-2019-107446
• Device Sequence Number: 19288824
• Product Code: JWH
• UDI-Device Identifier: 10603295135524
• UDI-Public: 10603295135524
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140881
• 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): 09/11/2019

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: 254500975
• Device Lot Number: BFA0P71
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 11/28/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 11/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization