MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 METAGLENE GUIDE PIN DIA 2.5MM; EXTREMITY INSTRUMENTS : PIN GUIDES

Model Number	2307-87-004
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Date of Event	03/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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 this was a tsa (total shoulder arthroplasty) treating left humeral fracture on (b)(6) 2020.The surgeon placed the positioning plate (230787003) to the scapular joint as per surgical technique.But s/he was unable to insert a guide pin (230787004) into the central hole of the positioning plate in question.The surgeon manually inserted the guide pin into the joint and completed the procedure less than 30-minute surgical delay.There was no harm to the patient.The device was the first use when the issue occurred.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary : the complaint was received into the company with the following comment: it was reported that this was a tsa (total shoulder arthroplasty) treating left humeral fracture on (b)(6) 2020.The surgeon placed the positioning plate (230787003) to the scapular joint as per surgical technique.But s/he was unable to insert a guide pin (230787004) into the central hole of the positioning plate in question.The surgeon manually inserted the guide pin into the joint and completed the procedure less than 30-minute surgical delay.There was no harm to the patient.The device was the first use when the issue occurred.The products were returned and were forwarded onto the supplier for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination(s).The suppliers report summarised: the dhr analysis of the batch returned show an initial conformance of this product with regards to its specification.For this batch, there was no deviation or non-conformance.The visual analysis of the returned product shows a deterioration in the central hole ø2.7.This deterioration was probably provoked by the spindle during the use of the product.Damage, marks at the entrance and exit of the ø2.7 hole.Pinning of the spindle which caused a bead of material and a reduction in the passage of the spindle.The product was initially in conformity.The non-functionality of the instrument is due to the deterioration of the hole.This analysis has not highlighted any supplier defect: the need of corrective actions is not indicated.It is stated that this was the first time the product had been used.However the lot number identified the product as five years old.The damage causing the products not to assemble was consistent with wear and tear.The full supplier report has been attached for reference.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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.
Additional Manufacturer Narrative
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 caused or contributed to the potential event described in this report.Corrected: d11 the previous concomitant products reported are being retracted since they were reported in error.H6 patient code: no code available (3191) used to capture the surgery prolonged and insufficient information.

• Brand Name: METAGLENE GUIDE PIN DIA 2.5MM
• Common Device Name: EXTREMITY INSTRUMENTS : PIN GUIDES
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 9928995
• Report Number: 1818910-2020-10248
• Device Sequence Number: 2415820
• Product Code: LXH
• UDI-Device Identifier: 10603295116455
• UDI-Public: 10603295116455
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/17/2020

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: 2307-87-004
• Device Catalogue Number: 230787004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 05/13/2020; 06/25/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 05/18/2020; 06/26/2020
• 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: METAGLENE GUIDE PIN DIA 2.5MM; METAGLENE POSITIONER PLATE