MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT ANT STEM INSERT SHAFT; HIP INSTRUMENTS : INSERTION DEVICES

Model Number	2598-07-450
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/10/2020
Type of Reportable Event	Malfunction
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
Summit anterior inserter broke during final insertion of the summit stem.Surgical delay of five minutes.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.Depuy-synthes 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.The previous g4 was incorrectly submitted and corrected to 9/11/2020.
Event or Problem Description
Additional information was received stating that the very tip that is used to center the inserter in the summit stem broke.The two rotational wings did not break, just the small tip at the very distal part of the stem inserter.Just one was broken and requested that all five be updated so this wouldn¿t happen again.Several xrays had been taken at various angles to view any broken (free floating) pieces.Nothing was seen under x-ray.Furthermore, nothing seemed to be restricting the non-broken inserter from fully seating into the stem.
Event or Problem Description
Additional information was received stating that the very tip that is used to center the inserter in the summit stem broke.The two rotational wings did not break, just the small tip at the very distal part of the stem inserter.Just one was broken and requested that all five be updated so this wouldn¿t happen again.Several xrays had been taken at various angles to view any broken (free floating) pieces.Nothing was seen under x-ray.Furthermore, nothing seemed to be restricting the non-broken inserter from fully seating into the stem.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.Depuy-synthes 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.H10 additional narrative: corrected: g1, g2.

• Brand Name: SUMMIT ANT STEM INSERT SHAFT
• Common Device Name: HIP INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10442894
• Report Number: 1818910-2020-18598
• Device Sequence Number: 2795088
• Product Code: HWR
• UDI-Device Identifier: 10603295148432
• UDI-Public: 10603295148432
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup,Followup
• Report Date (Section B): 08/11/2020

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 Model Number: 2598-07-450
• Device Catalogue Number: 259807450
• Device Lot Number: PG267826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 08/11/2020; 09/11/2020; 09/11/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 08/27/2020; 09/15/2020; 09/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR