MAUDE Adverse Event Report: SYNTHES GMBH VA-LCP CLAVICLE PLATE 2.7 MED LE TAN; PLATE, FIXATION, BONE

Catalog Number	04.112.630S
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022, the patient underwent the open reduction internal fixation with the va-lcp clavicle plate for the distal and proximal fracture of the right clavicle.The sales rep arranged va-lcp clavicle plate sets and an optional plate for inside right.However, it was confirmed that the optional plate was for left during the surgery.The sales rep had ordered a wrong optional plate (04.112.630s).The surgeon substituted an outer plate (04.112.611s) for the proximal clavicle.The surgery was completed successfully without any surgical delay.No further information is available.This report is for one (1) va-lcp clavicle plate 2.7 med le tan.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Product complaint #: (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.Without a lot number the device history records review could not be completed.Product was not returned.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.

• Brand Name: VA-LCP CLAVICLE PLATE 2.7 MED LE TAN
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14397388
• Report Number: 8030965-2022-03190
• Device Sequence Number: 14825199
• Product Code: HRS
• UDI-Device Identifier: 07612334214508
• UDI-Public: (01)07612334214508
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/13/2022

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: 04.112.630S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - CONSTRUCTS: VA-LCP PLATE/SCREWS-TIBIA; VA-LCP CLAVICLE PLATE 2.7 LAT CS1 R TAN
• Patient Sex: Unknown