MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 DXTEND HUMERAL SPACER +9MM; DELTA XTEND IMPLANTS : SHOULDER HUMERAL SPACER

Catalog Number	130730009
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
Intraoperatively theatre staff tried to insert the spacer several times.It needs to be at the same distance from the stem all round.As this simply did not work after six attempts, they used another one instead.
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: d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H3.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : intraoperatively theatre staff tried to insert the spacer several times.It needs to be at the same distance from the stem all round.As this simply did not work after six attempts, they used another one instead.The product was not returned to depuy synthes, however photos were provided for review.(b)(4).Photos were provided for review, however the photos only show part and lot number and no other observation pertaining to the nature of the reported event could be identified.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the photographs provided contained insufficient evidence of the reported event.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : 1) quantity manufactured: (b)(4), 2) date of manufacture: 08/25/2022, 3) any anomalies or deviations identified in dhr: none, 4) expiry date: 07/31/2027, 5) ifu reference: w90930 rev.D.
Event or Problem Description
Additional information was received: a.Was there a surgical delay? what is the duration of the delay? no significant delay, about 5 min.B.Were there any adverse consequence/s that affected the patient because of the reported event? no.
Additional Manufacturer Narrative
Product complaint(b)(4).Investigation summary intraoperatively theatre staff tried to insert the spacer several times.It needs to be at the same distance from the stem all round.As this simply did not work after six attempts, they used another one instead.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device found light marks at the surface of the sample, most likely due to the attempts to place it.A functional test was not performed due to the mating device was not returned.A dimensional inspection was performed and the device met specifications.The overall complaint was not confirmed as the observed condition of the dxtend humeral spacer +9mm would not contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Drawing/specifications reviewed? dwg - 8e070031 rev.C current and manufactured.Dimensional inspection: specified dimensions device upper diameter = 38.65 +/- 0.2 mm gauge diameter = 32.35 +/- 0.03 mm device upper width = 9.1 + 0.3 mm measured dimensions: device upper diameter = 38.65 mm (complies) gauge diameter = 32.33 mm (complies) device upper width = 9.24 mm (complies) device used: mitutoyo digimatic caliper #cd78620 device history lot 1) quantity manufactured: 20 2) date of manufacture: 08/25/2022 3) any anomalies or deviations identified in dhr: none 4) expiry date: 07/31/2027 5) ifu reference: (b)(4).Rev.D device history review 1) quantity manufactured: 20 2) date of manufacture: 08/25/2022 3) any anomalies or deviations identified in dhr: none 4) expiry date: 07/31/2027 5) ifu reference: (b)(4).Rev.D added: d4 expiration h3.

• Brand Name: DXTEND HUMERAL SPACER +9MM
• Common Device Name: DELTA XTEND IMPLANTS : SHOULDER HUMERAL SPACER
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19171827
• Report Number: 1818910-2024-08913
• Device Sequence Number: 17972955
• Product Code: HSD
• UDI-Device Identifier: 10603295027348
• UDI-Public: 10603295027348
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K192855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup

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 Catalogue Number: 130730009
• Device Lot Number: 5416481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 05/21/2024; 05/27/2024; 05/28/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 05/22/2024; 05/27/2024; 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown