MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 BROACH CORAIL AMT 8; HIP INSTRUMENTS : BROACHES

Catalog Number	L20408
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Not Applicable (3189)
Date of Event	10/07/2019
Type of Reportable Event	Serious Injury
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
Was the surgery prolonged due to the event? if yes, confirm how many minutes delay- 1 hour.While broaching a femur with broach size 8, a fracture appeared in the calcar.
Additional Manufacturer Narrative
(b)(4).
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 heen able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not bsynthes 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 lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.Following review by bioengineering, notification was received that: "due to the lack of information available it is not possible to establish a root cause, either for the calcar fracture or the collared stem failing to seat.Specifically "the complaint questions why there is no size 7 stem available at this time? can this be investigated and any future plans to manufacture a size 7 stem be relayed back".The depuy international research & development hip npd team were contacted regarding the above query.The following response addresses the complaint questions: "depuy synthes are developing size 7 stems (and broach) for the corail system, they are not currently launched.This device is only currently planned to be launched to the japanese market, and therefore is not planned to be made available in the ireland market.All complaints received by depuy synthes are logged in a complaint system, and complaints are trended for complaint triggers.We have a dedicated team who will respond appropriately if a trend around deficiencies in the size range of corail is identified".The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.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 will be filed as appropriate.

• Brand Name: BROACH CORAIL AMT 8
• Common Device Name: HIP INSTRUMENTS : BROACHES
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 9261006
• Report Number: 1818910-2019-113376
• Device Sequence Number: 366526
• Product Code: HTQ
• UDI-Device Identifier: 10603295258100
• UDI-Public: 10603295258100
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: L20408
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 10/07/2019; 01/09/2020
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 11/04/2019; 01/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention