MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL AMT SZ10 125 STD COL; CORAIL LINE EXTENSION IMPLANTS : HIP FEMORAL STEM

Model Number L971210

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2022

Event Type  malfunction  

Event Description

It was reported that when went to pass stem, circulator noticed a puncture hole in top of sterile packaging.Did not occur while opening package or hand off to circulator.No signs of puncture on cardboard box, cardboard insert, or cellophane wrap.Stem never was passed as we noticed prior to passing it.Surgical delay of 12 minutes occurred.Doi: unknown, dor: (b)(6) 2022; affected side: right hip.

Manufacturer Narrative

Product complaint #(b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d3, g1, h3.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this complaint was received for examination.Visual examination found the reported puncture hole in the inner package, however the allegation against the receipt status of the package cannot be confirmed since the outer package has already been opened and no manufacturing nonconformance related to the current complaint was found.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: a dhr review was performed and 4 non-conformances were found that are not related to the current complaint failure mode.

• Brand Name: CORAIL AMT SZ10 125 STD COL
• Type of Device: CORAIL LINE EXTENSION IMPLANTS : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• Manufacturer (Section G): DEPUY FRANCE SAS 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15481485
• MDR Text Key: 305933777
• Report Number: 1818910-2022-18654
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295455400
• UDI-Public: 10603295455400
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192946
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/24/2022

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
• Device Operator: Health Professional
• Device Model Number: L971210
• Device Catalogue Number: L971210
• Device Lot Number: 9056160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2022
• Initial Date FDA Received: 09/24/2022
• Supplement Dates Manufacturer Received: 09/26/2022; 11/01/2022
• Supplement Dates FDA Received: 09/27/2022; 11/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female