MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND MOD EPI 1 ECC LEFT HA; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY

Model Number	130720102
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	08/10/2020
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
It was reported that a patient underwent an orthopedic procedure on (b)(6) 2020.Upon opening the implant, the internal sterile package was not fully sealed in a corner.Another like device was used to complete the procedure.There were no adverse events or patient consequences reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device and packaging components associated with this report were not returned for examination.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.

• Brand Name: DXTEND MOD EPI 1 ECC LEFT HA
• Common Device Name: DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 10426783
• Report Number: 1818910-2020-18388
• Device Sequence Number: 2990697
• Product Code: KWS
• UDI-Device Identifier: 10603295027294
• UDI-Public: 10603295027294
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K021478
• 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
• Report Date (Section B): 08/10/2020

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: 130720102
• Device Catalogue Number: 130720102
• Device Lot Number: 5349037
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 08/19/2020
• Supplement Report FDA Received Date: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR