MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT BROACH EXTRACTOR; HIP INSTRUMENTS : EXTRACTION INSTRUMENTS

Catalog Number	257000002
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	09/10/2019
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
C-stem pinnacle thr: (b)(6) 2019.When they were broaching to prepare the femur, the scrub nurse noticed that the end of the broach handle was damaged.When the surgeon is removing the broach handle with the mallet as per the surgical technique, they could see the end of the broach handle detaching from the main unit.They then had to open the loan set on site to use that broach handle in order to complete the procedure.This added a minor delay of +/- 5mins while we opened the set.Desired outcome was achieved.Female patient, approximately (b)(6).
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 : no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.The lot number identified the product as being 33 years old.It is suspected that the cause of the issue may have been wear and tear, but without the product returned, this cannot be confirmed.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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.Device history lot : null.Device history batch : null.Device history review : null.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: SUMMIT BROACH EXTRACTOR
• Common Device Name: HIP INSTRUMENTS : EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9140299
• Report Number: 1818910-2019-107005
• Device Sequence Number: 16879272
• Product Code: HTQ
• UDI-Device Identifier: 10603295142850
• UDI-Public: 10603295142850
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2019

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: 257000002
• Device Lot Number: AK0986
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR