MAUDE Adverse Event Report: SYNTHES GMBH 130 DEG LCP DHS PLATE-STANDARD BARREL 2 HOLES/60MM-STERILE; PLATE,FIXATION,BONE

Catalog Number 02.224.202S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed.No conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, one (1) dhs plate and one (1) dhs lag screw did not fit together.It is unknown if there was patient or surgical involvement.There is no further information available.This report is for one (1) 130 deg lcp dhs plate-standard barrel 2 holes/60mm-sterile.This is report 1 of 2 for (b)(4).

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 that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D4 d9 g1 h3, h6: part: 02.224.202s lot: 90p8537.Manufacturing site: grenchen.Release to warehouse date: 11 march 2021.Expiry date: 01 march 2031.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Visual inspection: the lcp dhs-pl 130° 2ho l60 standbarrel sst (part #: 02.224.202s, lot #: 90p8537) was received at us customer quality (cq).Visual inspection of the complaint device showed no damage or defect.Functional test: a functional assessment was not performed as the returned mating part was deformed.Also this complaint device did not exhibit any issue that warranted functional assessment.Can the complaint be replicated with the returned device? unable to assess.Dimensional inspection: measured dimensions.Guide internal flat diameter: 7.22mm pin gage went in.Guide internal flat diameter: 7.24mm pin gage did not go in.Document/specification review: current and manufactured were reviewed.No design issues or discrepancies were identified.Complaint confirmed? no.Investigation conclusion: this complaint is not confirmed as there was no defect observed from the visual inspection of the returned plate.The device was unable to assemble with the screw because the screw was deformed at its proximal end.No root cause could definitively be determined for the reported complaint condition.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 130 DEG LCP DHS PLATE-STANDARD BARREL 2 HOLES/60MM-STERILE
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11976089
• MDR Text Key: 255429711
• Report Number: 8030965-2021-04779
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819820968
• UDI-Public: (01)07611819820968
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.224.202S
• Device Lot Number: 90P8537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Date Manufacturer Received: 06/25/2021
• Patient Sequence Number: 1