MAUDE Adverse Event Report: DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655 CANCELLOUS BONE SCREW 6.5X30MM; BONE SCREWS AND PINS : SCREWS

Catalog Number	117230000
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Infarction, Cerebral (1771); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Rash (2033)
Date of Event	10/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
Revision due to infection.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.Product complaint # = > (b)(4).Investigation summary = > a review of complaints databases and manufacturing records did not identify any anomalies.Root cause undetermined.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.

• Brand Name: CANCELLOUS BONE SCREW 6.5X30MM
• Common Device Name: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8146997
• Report Number: 1818910-2018-77674
• Device Sequence Number: 1498352
• Product Code: HRS
• UDI-Device Identifier: 10603295007623
• UDI-Public: 10603295007623
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 117230000
• Device Lot Number: HU1112
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/10/2018
• Supplement Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 02/08/2019
• 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: Required Intervention
• Patient Age: 42 YR