MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 GL AP 3.2MM OSTEO GD PIN LONG; EXTREMITY INSTRUMENTS : PIN GUIDES

Catalog Number	213020000
Medical Device Problem Codes	Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 when the item arrived at the office, the package which should have held a global osteotome guide pin, was empty.A hospital and surgery not involved.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint: (b)(4).Investigation summary: examination of the returned packaging confirms the reported event of a missing pin within the packaging.The root cause is attributed to human error.Nr(b)(4) has been opened to document the supplier scar (supplier corrective action request) due to the reported event.There was a correct typo for the quantity and amount at final inspection but do not believe this would have led to the part not being included in the package.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: GL AP 3.2MM OSTEO GD PIN LONG
• Common Device Name: EXTREMITY INSTRUMENTS : PIN GUIDES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7503361
• Report Number: 1818910-2018-59332
• Device Sequence Number: 13498727
• Product Code: LXH
• UDI-Device Identifier: 10603295090809
• UDI-Public: 10603295090809
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2018

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: 213020000
• Device Lot Number: AF1006001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Initial Date Received by Manufacturer: 04/13/2018
• Supplement Date Received by Manufacturer: 05/22/2018; 06/12/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 05/24/2018; 06/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1