MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND SCREW LOCK D4.5X48MM; DELTA XTEND IMPLANTS : SCREWS

Model Number	130790048
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/27/2020
Type of Reportable Event	Serious Injury
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
Revision right delta xtend tsr.Patient underwent primary surgery in 2012 at another facility and different surgeon.Presented to current surgeon complaining of pain.Surgeon suspected cause as scapular notching.Surgery undertaken to remove poly insert, glenosphere and broken inferior metaglene screw.Broken portion of screw unable to be removed and left in-situ.Previous 38 ecc glenosphere removed and a 42 ecc inserted.Trail reduction with 42, + 6 std poly insert.Surgeon satisfied with range of motion, definitive 42, + 6 std poly impacted and shoulder reduced.
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.H10 additional narrative: added: g1 (zip code extension).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: g1 (physical manufacturer).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Visual examination of the provided photographs and x-ray images confirmed the reported event.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot : the dhr analysis of the batches indicated shows an initial conformance of these products with regards to their specification.For these batches, there was no deviation or non-conformance.

• Brand Name: DXTEND SCREW LOCK D4.5X48MM
• Common Device Name: DELTA XTEND IMPLANTS : SCREWS
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 11006434
• Report Number: 1818910-2020-26921
• Device Sequence Number: 17242274
• Product Code: KWS
• UDI-Device Identifier: 10603295027874
• UDI-Public: 10603295027874
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K120174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• 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
• Report Date (Section B): 11/27/2020

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 Model Number: 130790048
• Device Catalogue Number: 130790048
• Device Lot Number: 5124369
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/27/2020
• Supplement Date Received by Manufacturer: 11/27/2020; 02/19/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 12/17/2020; 02/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BIOSTOP G CEM RESTR 12MM; DXTEND GLENOSPHERE ECC D38MM; DXTEND MBLOC HUM EPI 1 D12 STD; DXTEND METAGLENE; DXTEND RETENT PE CUP D38 +6MM; DXTEND SCREW LOCK D4.5X30MM; DXTEND SCREW LOCK D4.5X30MM; DXTEND SCREW LOCK D4.5X42MM; BIOSTOP G CEM RESTR 12MM; DXTEND GLENOSPHERE ECC D38MM; DXTEND MBLOC HUM EPI 1 D12 STD; DXTEND METAGLENE; DXTEND RETENT PE CUP D38 +6MM; DXTEND SCREW LOCK D4.5X30MM; DXTEND SCREW LOCK D4.5X30MM; DXTEND SCREW LOCK D4.5X42MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR