MAUDE Adverse Event Report: SYNTHES GMBH UNK - BONE STAPLE

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

Patient Problems Numbness (2415); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Date of event in unknown.510k: this report is for an unk - bone staple/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 poland as follows: this report is being filed after the review of the following journal article: liszka, h., and gadek, a.(2019), comparison of the type of fixation of akin osteotomy, foot & ankle international, vol.40(4), pages 390-397 (poland).The objective of the study was to assess the influence of the type of fixation of the akin osteotomy when used during hallux valgus surgery.Between 2013 and 2016, a total of 138 akin osteotomy procedures were used using a staple (group a = 43 patients), screws (group b = 47 patients) and single or double transosseous suture stabilization (group c = 48 patients).There were 3 males and 43 females in group a with an average age of 53 ± 35 years.The following complications were reported as follows: 1 patient complained of staple soft tissue irritation 4 cases had lateral cortex breached.Bone union was achieved with proper positioning, without any clinical consequences.2 patients had transient numbness this report is for an unknown synthes bme staples.This report is for (1) unk - bone staple this report is 1 of 1 for (b)(4).Related product complaint: (b)(4).

• Brand Name: UNK - BONE STAPLE
• Type of Device: BONE STAPLE
• 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: 11463317
• MDR Text Key: 248047840
• Report Number: 8030965-2021-01862
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/19/2021

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2021
• Initial Date FDA Received: 03/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention