MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM LCP SUP ANT CLAVICLE PL W/LAT EXTN 7H/RT/123MM; PLATE, FIXATION, BONE

Model Number	02.112.018
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reporter is a synthes employee.Photo investigation: the complaint device was not returned for investigation.A photo analysis was completed on the received images.The images were reviewed and 3.5mm lcp superior anterior clavicle plates had broken in its implanted position.The root cause of the issue cannot be determined from the available information.Manufacturing record evaluation could not be performed as no lot number information was available.Since the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint condition of broken plate could be confirmed from the images.During the investigation, no product design issues, or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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 or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that patient will undergo revision surgery due to a broken plate.The doctor reports that the clavicle plate placed on the patient has broken due to fatigue, for which they are going to remove the implant and place another one.Patient also experienced pain.This report is for a 3.5mm locking compression plate (lcp) sup ant clavicle plate.This is report 1 of 1 for (b)(4).

• Brand Name: 3.5MM LCP SUP ANT CLAVICLE PL W/LAT EXTN 7H/RT/123MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12306816
• Report Number: 8030965-2021-06565
• Device Sequence Number: 3611548
• Product Code: HRS
• UDI-Device Identifier: 10886982032713
• UDI-Public: (01)10886982032713
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K111540
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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
• Report Date (Section B): 07/12/2021

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: 02.112.018
• Device Catalogue Number: 02.112.018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 08/11/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention