MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: LC-DCP PLATE/SCREWS; ROD, FIXATION, INTRAMEDULLARY

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

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.This report is for an unknown constructs: lc-dcp plate/screws/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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 the united kingdom as follows: this report is being filed after the review of the following journal article: oliver, w.M.Et al.(2021), open reduction and internal fixation for humeral shaft nonunion: bone grafting is not routinely required and avoids donor site morbidity, journal of orthopedic trauma, vol.35, number 8, pages 414-423 (united kingdom).The aim of this study was to document the union rate, complications, and patient-reported outcomes of open reduction and internal fixation (orif), with and without bg, for patients with a humeral diaphyseal nonunion after failed nonoperative management.From 2008 to 2017, a total of 83 patients [mean age 59 years (range 17¿86)) underwent nonunion orif (plate and screws) at a mean of 7 months postinjury.Eleven underwent supplementary bg.A single plate was used in all cases and interfragmentary lag screws were used in 57 patients.Locking plates were used in 59 (n = 51/86) and consisted of a 3.5 mm (10%, n = 9/86) or 4.5 mm (10%, n = 9/86) straight locking compression plate or anatomical equivalent (philos; depuy synthes, zuchwil, switzerland; 38%, n = 33/86).Standard 3.5 mm (31%, n = 27/86) or 4.5 mm (9%, n = 8/86) dynamic compression plates were used in the remainder.The following complications were reported as follows: 13 patients had died.19 patients reported mild pain.13 patients reported moderate pain.4 patients reported severe pain.A 59-year-old female patient was treated with a 3.5 mm dcp (neut) and 1 lag screw.She had an aseptic nonunion.1st revision orif with icbg (4wk postop).Recurrent nonunion, fixation failure.2nd revision orif (59 wk post-op).Eventual union 3.3 y postinjury.A 71-year-old male patient was treated with a philos plate (comp) and 1 lag screw.He had an asceptic union and fixation failure.He was asymptomatic and functional.No further management.A 77-year-old female patient was treated with a 3.5 mm dcp (comp) and 1 lag screw.She had an asceptic union and fixation failure.1st revision orif with icbg (62 wk postop).Recurrent nonunion.2nd revision orif with icbg (159 wk postop).A 66-year-old female patient was treated with 4.5 mm lcp (neut) and 2 lag screws.She had an infected nonunion (staph.Epidermidis) and fixation failure.Single-stage revision orif (21 wk postop).A 55-year-old female patient was treated with a philos plate (comp) and 1 lag screw.She had late presentation infected nonunion (strep.Canis, staph.Warnerii, and bacillus spp.).Two-stage revision orif (95 & 130 wk postop).A 62-year-old female patient was treated with a 3.5 mm dcp (neut) and 2 lag screws.She had an asceptic nonunion and fixation failure.Revision orif (37 wk postop).Eventual union 2.3 y postinjury.This report is for an unknown synthes dcp, lcp and philos.A copy of the literature article is being submitted with this report.This is report 2 of 7 for (b)(4).Please note regarding the 13 deaths: this report provides little to no information concerning the patient deaths.The patient population ranges from age 17 -86 and the injury mechanisms and baseline patient characteristics are varied.There is no notation of any perioperative deaths.Given this information, it is unlikely that these deaths are related to the implant device.

• Brand Name: UNK - CONSTRUCTS: LC-DCP PLATE/SCREWS
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15114748
• MDR Text Key: 296757219
• Report Number: 8030965-2022-05283
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• 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: 06/29/2022
• 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