MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: HUMERAL NAIL; NAIL, FIXATION, BONE

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

Patient Problems Nerve Damage (1979); Paralysis (1997); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).510k: this report is for an unk - constructs: humeral nail/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.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 france as follows: this report is being filed after the review of the following journal article: colombi, r.Et al.(2019), is distal locking screw necessary for intramedullary nailing in the treatment of humeral shaft fractures? a comparative cohort study, international orthopedics, vol.43, pages 2151¿2160 (france) the objective of this study was to evaluate clinical and radiographic outcomes between two groups of humeral shaft fracture treated with antegrade intramedullary nailing (imn) with and without distal interlocking.Between january 1, 2009 and september 31, 2016, a total of 120 patients with 121 fractures underwent antegrade imn.They were divided into 2 groups; 74 patients in the wdi (without distal interlocking screw) group which has of 40 males and 34 females, and 47 patients in the di (distal interlocking screw) group which has 20 males and 27 females.Four solid humeral nails were used (multiloc (depuy-synthes, bristol, usa) in 68 cases, t2 (stryker, kalamazoo, usa) in 50 cases, versa (depuy-synthes, bristol, usa) in 2 cases, and trigen (smith & nephew, london, uk) in 1 case.The article did not specify which of the devices were being used to capture the following complications: 14 patients died there were 11 nerve palsies (10 radial palsies and 1 brachial plexus), including four postoperative palsies (2 per group), and all of the radial palsies resolved spontaneously.6 patients had nonunion.5 were eutrophic.1 was atrophic.2 patients were paralyzed (tetraplegic and brachial plexus).This report is for an unknown synthes 4 solid humeral nails were used (multiloc (depuy-synthes, bristol, usa).A copy of the literature article is being submitted with this medwatch.This report is for (1) unk constructs: humeral nail this report is 1 of 4 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: HUMERAL NAIL
• Type of Device: NAIL, 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: 11457122
• MDR Text Key: 249236175
• Report Number: 8030965-2021-01839
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• 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: 02/12/2021
• 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