MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 GLO FX/ADV INSERTER/EXTRACTOR; EXTREMITY INSTRUMENTS : IMPACTION INSTRUMENTS

Catalog Number	212801020
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complaint sample consisted of (1) 212801020 glo fx/adv inserter/extractor.The date code ah0703 indicates this device was manufactured in july 2003.Examination of the returned product found no deficiencies with the device.Functional evaluation identified the locking handle and tab exhibited a slight toggle consistent with normal wear of the mechanical joint components of the locking mechanism.The device exhibits heavy impaction marks and nicks through normal use and servicing.The root cause is attributed to wear through normal use and servicing.Based on the determination of the wear through normal use and servicing as the root cause, the need for corrective action is not indicated.Complaint trends will be monitored by post market surveillance through (b)(4).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.
Event or Problem Description
After investigation, it was reported that the device was scratched/nicked.
Additional Manufacturer Narrative
(b)(4).The investigation identified the returned device was worn.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: GLO FX/ADV INSERTER/EXTRACTOR
• Common Device Name: EXTREMITY INSTRUMENTS : IMPACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8584197
• Report Number: 1818910-2019-92650
• Device Sequence Number: 10836931
• Product Code: LXH
• UDI-Device Identifier: 10603295088028
• UDI-Public: 10603295088028
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2019

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: 212801020
• Device Lot Number: AH0703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Initial Date Received by Manufacturer: 04/30/2019
• Supplement Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1