MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DELTO PECTORAL CUTTING GUIDE; EXTREMITY INSTRUMENTS : RESECTION BLOCKS/DEVICES

Model Number	2307-72-003
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Delta xtend reverse shoulder procedure: deltoid pectoral cutting guide was attached to the handle for cutting guide (instrumentation at this point was in the humerus of patient) when surgeon tried to remove instrumentation to proceed, the deltoid pectoral guide would not detach from handle as per surgical technique the two instruments fused together.The surgeon subsequently removed both instruments attached to one another using a mallet.Surgical delay 3 minutes and procedure successfully completed.
Additional 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : examination of the returned device could not confirm the reported jammed/seized condition with a mating handle instrument.The device was returned without the mating instrument.Examination of the returned device revealed one of the locking knobs was stripped.The noted damage is consistent with the use of excessive force and the investigation did not establish a need for corrective action.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 : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: DELTO PECTORAL CUTTING GUIDE
• Common Device Name: EXTREMITY INSTRUMENTS : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 11561105
• Report Number: 1818910-2021-05926
• Device Sequence Number: 14498870
• Product Code: HTZ
• UDI-Device Identifier: 10603295116080
• UDI-Public: 10603295116080
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/08/2021

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: 2307-72-003
• Device Catalogue Number: 230772003
• Device Lot Number: 5117323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 04/29/2021; 04/29/2021; 05/20/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 05/10/2021; 05/13/2021; 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1