MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: PFNA ROD, FIXATION, INTRAMEDULLARY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

(b)(4). Additional narrative: this report is for an unk - constructs: pfna /unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed and no conclusion could be drawn at the time of filing this report. Product was not returned. Based on the information available, it has been determined that no corrective and 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: this report is being filed after the review of the following journal article: yamamoto, y. Et al. (2020), radiological findings and outcomes of anterior wall fractures in pertrochanteric fractures, journal of orthopedic science, vol. Xx, pages 1-7 (japan) the aim of this study is to investigate the prevalence and clinical findings of anterior wall fractures in this comparative cohort study. Between 2013 and 2016, a total of 516 patients underwent internal fixation. The implants used were the omega plus ti compression hip screw system (stryker); the cephalomedullary nail was gamma3 (stryker), proximal femoral nail antirotation (depuy synthes), natural nail cephalomedullary asia nail (zimmer biomet), trigen intertan (smith & nephew), or om femoral nail system (omic). The article did not specify which of the devices were being used to capture the following complications: 44 patients had anterior wall fractures. 28 patients had anterior wall fractures with a minimum follow-up of 3 months. 8 patients had an unacceptable reduction status on immediate postoperative radiographs. This report is for an unknown synthes pfna. A copy of the literature article is being submitted with this medwatch. This report is for (1) unk - constructs: pfna this report is 1 of 1 for pc-000856839.

• Brand Name: UNK - CONSTRUCTS: PFNA
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11467285
• Report Number: 8030965-2021-01881
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown
• Patient Outcome(s): Required Intervention