MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX25MM; BONE SCREWS AND PINS : SCREWS

Model Number 1217-25-500

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 07/21/2020

Event Type  malfunction  

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 Description

Empty packing.It was reported that during the surgery of total hip replacement operation, opened the packing (could not find this issue if did not open the packing), noted no product in the packing.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned packaging materials confirms the reported observation.Based on the condition of the inner packaging materials it is difficult to conclude it was distributed in this condition.No error in initial processing is suspected.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot: lot pu154657.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Device history review: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

• Brand Name: PINN CAN BONE SCREW 6.5MMX25MM
• Type of Device: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10713056
• MDR Text Key: 212474386
• Report Number: 1818910-2020-22960
• Device Sequence Number: 1
• Product Code: NDJ
• UDI-Device Identifier: 10603295009900
• UDI-Public: 10603295009900
• Combination Product (y/n): N
• PMA/PMN Number: K983014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1217-25-500
• Device Catalogue Number: 121725500
• Device Lot Number: PU154657
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/05/2020
• Date Manufacturer Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1