MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: PLATE/SCREWS; SCREW, FIXATION, BONE

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

Patient Problems Loss of Range of Motion (2032); Impaired Healing (2378); Post Operative Wound Infection (2446); Muscle/Tendon Damage (4532)

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).510k: this report is for an unk - screws: spine/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, no product was received; no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, no further action is required at this time.Complaint information is trended on a regular basis to determine if further investigation is warranted.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: lv f., (2021) comparative analysis of the effects of ao miniplate and kirschner wire pinning in the metacarpal fractures, medicine volume 100, pages 1-6 (china).This retrospective study aims to compare and analyze the application effect of ao mini-plate screw and kw fixation in the treatment of metacarpal fracture, which is reported as follows.March 2016 to march 2019, 590 patients with the metacarpal fracture were admitted and recruited in this study including 335 males and 255 females.The mean age of the patients was 28.45 years (range 18¿45years).Three hundred patients (178 males and 122 females) age 29.45±2.51 years treated with ao mini plate and screw fixation were included in the ao group, and 290 patients (157 males and 133 females) age 27.5±3.31 years treated with kw fixation were included in the kw group.Patients in both groups were followed up for 3 to 6months after operation.The following complications were reported: 7 wound infection, 7 tendon adhesion, 5 delayed healing, 4 loss of extension compared with contralateral digit, degree (range 1-25), 10 loss of flexion compared with contralateral digit, degree (range 0-70), 20 bad recovery of affected limb joint function 3 months after operation.6 loose internal fixation.This report is for an unknown synthes ao mini plate and screw.This report is for one (1) unk - constructs: plate/screws.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.H3, h6: the investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Product was not returned.Based on the information available, no further action is required at this time.Complaint information is trended on a regular basis to determine if further investigation is warranted.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: UNK - CONSTRUCTS: PLATE/SCREWS
• Type of Device: SCREW, FIXATION, BONE
• 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: 12665817
• MDR Text Key: 277438619
• Report Number: 8030965-2021-08819
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• 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
• Date Manufacturer Received: 11/26/2021
• 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